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Premium surgical sutures
Needle properties
Suture Materials
Specification of suture materials
Application examples of suture materials
ONATEC item overview
Highlights
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PREMIUM SURGICAL SUTURES Surgical sutures are certifi ed medical devices, which re- place the mechanical bridging function of missing tissue integrity in the short, medium or long term. For quick and good wound healing, the sutures should create the greatest possible contact between the separated tissue parts. Demanding ophthalmic surgical applications require high-quality sutures for the best possible wound adaptation while at the same time minimizing tissue trauma. Geuder AG offers a broad portfolio of surgical needles and sutures from Onatec® for almost all ophthalmic surgical indications that require precise stitches. Onatec® sutures meet the highest surgical demands and yield optimal results with little scarring. Onatec® stands for quality products made in Germany, which were developed with leading surgeons to offer practical and effective solutions for ophthalmology. THE NEEDLES – HIGHEST PRECISION IN ITS SMALLEST SCALE Onatec® needles are made from a highly tempered and virtually unbreak- able special steel with high bending resistance. Due to the innovative and highly automated manufacturing process, precise needle geo- metries and accurate needle grinds can be realized, which enable stitching of the fi nest types of tissue in the smallest space. The high-quality surface fi nishing of many Onatec® needles offers optimal penetration and thus little trauma to the tissue. The result is a reliable wound adaptation with barely visible scars for the best possible restoration of tissue function. 2 QUALITY FACTORS

OPTIMIZED PENETRATION FOR THE HIGHEST OPHTHALMIC SURGICAL REQUIREMENTS: Penetration Test of Reverse Cutting Needles Acculine test device – Test media : Povar foil 0.4 mm (Source: FSSB Chirurgische Nadeln GmbH) * r e t t e b 0,7 0,6 0,5 0,4 0,3 0,2 0,1 0 ] N [ e c r o F 0 100 200 300 400 Depth [μm] QUALITY FEATURES OF ONATEC® NEEDLES: · High resistance to bending and breakage · Optimized penetration · Accurate grind of the needle tip shape · Low tissue trauma Competitor A, rev. cut. 25-68 Competitor B, rev. cut. 25-68 Optimized penetration Onatec®, DDK 25-68 Plastic surgery needle of market leader Optimized penetration Onatec®, DDKL 25-68 * less penetration force required STEEL QUALITY NEEDLE GEO- METRY NEEDLE TIP SHAPE SURFACE FINISHING QUALITY FACTORS 3

NEEDLE PROPERTIES SUTURE TECHNIQUE AND TISSUE DETERMINE THE SPECIFICATIONS OF THE NEEDLE THE FOLLOWING FEATURES HAVE AN IMPACT: Chord length (stitch width) · Needle shape (cross-section) · Needle tip · Needle diameter · Curvature · Arc length (needle length) · Armed (The choice between single and double armed enables different techniques or a more cost-effective use) Suture Needle tip Shaft / Swage Needle diameter Needle Body Arclength (need l e l e n g t h ) ) h c t i t s f o h t p e d i ( s u d a R NEEDLE SHAPE AND NEEDLE TIP * ** *** * ** *** * ** *** RS = Taper Point DS = Taper Cutting DSL = Soft Cutting Point * ** *** * ** *** DK = Reverse Cutting LZ(L) = Spatula Cross-section needle tip * ** Cross-section needle body *** Cross-section suture channel 4 NEEDLE PROPERTIES

SUTURE MATERIALS SUTURE MATERIALS FOR OPTIMAL WOUND ADAPTATION OUTSTANDING PROPERTIES: SELECTION CRITERIA: · Absorption characteristics · · · Tissue compatibility Structure, texture and diameter Elasticity and strength · High tensile strength resp. tear resistance · · · Secure knot positioning Easy knot tying Low capillarity · Optimal tissue compatibility · Good sliding properties through tissue · Good visibility · Easy to use SUTURE DIAMETER UNITED STATES PHARMAKOPEIA (USP) DIAMETER [MM] EUROPEAN PHARMACOPOEIA (PH. EUR. OR EP) 11-0 10-0 9-0 8-0 7-0 6-0 5-0 4-0 3-0 6 SUTURE MATERIALS 0.010 – 0.019 0.020 – 0.029 0.030 – 0.039 0.040 – 0.049 0.050 – 0.069 0.070 – 0.099 0.100 – 0.149 0.1500 – 0.199 0.200 – 0.249 0.1 0.2 0.3 0.4 0.5 0.7 1 1.5 2

ABSORPTION CHARACTERISTICS AND TISSUE COMPATIBILITY Onatec® sutures are made from biocompatible raw materials for the best possible tissue compatibility. The absorb- able suture material ONASORB® PGA supports natural wound healing until the shape and function of the tissue are restored. The non-absorbable suture materials ONALENE®, ONABOND®, ONAFIL® SILK and ONALON® are used for permanent wound adaptation in order to restore tissue function. NON-ABSORBABLE SUTURE MATERIALS remain almost unchanged in the tissue (inert) and are integrated into the wound scar: ONALENE® made of polypropylene ONABOND® made of polyester ONAFIL® SILK made of silk ABSORBABLE MATERIAL is degradable by hydrolysis and adapts to the tissue during the healing phase. It increasingly loses its tensile strength and tear resistance: ONASORB® PGA made of polyglycolic acid PSEUDO-ABSORBABLE MATERIAL degrades over a longer period of time by exposure to light and mois- ture. It is recommended for tissues with long-term scarring: ONALON® made of polyamide MATERIAL STRUCTURE AND PROPERTIES MONOFILAMENT MATERIAL MULTIFILAMENT MATERIAL (BRAIDED, COATED) ADVANTAGES · No capillarity · No sawing effect · Easy to pull through tissue · Low traumatic effect · High tear resistance · Secure knot positioning · Smooth handling · Easy to use CHALLENGES · Knot tying requires practice · Higher stress to tissue because and experience of surface structure MATERIAL EXAMPLES · Polypropylene (ONALENE®) · Polyamide (ONALON®) · Silk (ONAFIL® SILK) · Polyglycolic acid (ONASORB® PGA) · Polyester (ONABOND®) * Absorption time is the time, in which the suture material loses 50 % of its knot tear resistance, not to be confused with complete material degradation SUTURE MATERIALS 7

SUTURE MATERIALS SPECIFICATIONS OF SUTURE MATERIALS ONASORB® PGA ONALON® ONALENE® ONABOND® ONAFIL® SILK ABSORBABILITY absorbable non-absorbable non-absorbable non-absorbable non-absorbable STRUCTURE COLORS multifi la- ment, braided mono- fi lament monofi lament monofi lament multifi la ment, braided multifi la ment, braided violet black blue black undyed / white green black violet 4-0 bis 8-0 undyed 5-0 and 6-0 USP (Diameter) 4-0 to 8-0 9-0 and 10-0 4-0 to 10-0 3-0 to 10-0 9-0 and 10-0 4-0 to 6-0 3-0 4-0 to 7-0 MATERIAL COATING ADDITIONAL FEATURES Polyglycolic acid (PGA) Polyamide (Nylon) Polypropylene (PP) Polyester (PES) Natural silk none none none Silicone NuSil MED- 2174 Silicone NuSil MED- 2174 Polyca- prolac- tone and Calcium stearate · Half-life period 2 · Especially smooth · High tear resistance · High tear resistance · Very smooth weeks · For plastic surgery with high tear resistance (skin suture) · Fine monofi laments · Optimal knot security especially for micro surgery · Durable · Durable · Special coating for minimum trauma to tissue due to delicate structure · Low mechanical foreign body effect ONASORB®, ONALON®, ONALENE®, ONABOND® and ONAFIL® are registered trademarks of BSF GmbH, Pößneck, Germany 8 SUTURE MATERIALS

APPLICATION EXAMPLES OF SUTURE MATERIALS ONASORB® PGA ONALON® ONALENE® ONABOND® ONAFIL® SILK · Strabismus VLZL 8,5 · Glaucoma 10-0 DLZL 6.2 · Blepharoplasty · Strabismus 7-0 DDK 7.8P 5-0 – 6-0 VLZ(L) 8.5 CLINICAL APPLICATION* Suture USP and needle type · Eyelid and con- junctiva suture 5-0 – 6-0 VLZ(L) 8.5 5-0 HLZ 8.5 · Extraocular muscle suture 5-0 VLZ(L) 8.5 · Sclera suture 7-0 DDK 7.8P · Scleral buckling · Scleral buckling 4-0 DLZL 19E 4-0 – 5-0 VLZ(L) 8.5 · Transcutaneous levator resection 7-0 DDK 7.8P · Hattenbach iris suture 10-0 GRS 2.0 · Hattenbach IOL fi xation 10-0 GRS 2.0 · Transscleral IOL fi xation 9-0 GLZL 16 · Eyelid and con- junctiva suture 7-0 – 8-0 DLZ(L) 6.4 · Transcutaneous levator resection (pediatric) 7-0 DLZ(L) 6.4 · Cornea suture, keratoplasty and fi xation of amnion 10-0 DLZ(L) 6.2 · Scleral buckling 5-0 DLZL 16E · Lateral tarsal strip 6-0 VLZL 8.0 · Blepharoplasty 7-0 – 8-0 DLZ(L) 6.4 · Chalazion, hordeolum and xanthelasma 7-0 – 8-0 DLZ(L) 6.4 · Pterygium 9-0 – 10-0 DLZL 6.4 · Glaucoma 10-0 DLZL 6.4 * We do not assume liability for the application examples. They are only suggestions from the relevant specialist literature and from training materials. SUTURE MATERIALS 9

ITEM OVERVIEW N eedle tip (cross-section) N eedle (original size) Arm ed m) N eedle dia m eter (µ m) N eedle length (m N eedle type Suture U SP Speciality Suture length (c m) Suture color C urvature Suture structure C oating Packaging unit 2x H DSL 13 350 5/0 45 undyed multi fi lament 1 PCL + Ca 2 24 2x H LZ LZL 5.5 200 2x H LZL 8 1x D DK 7.8 DK 7.8 LZ 6.4 200 LZL 11 300 LZL 11 300 2x 1x 1x 2x 2x 1x D D D D D D LZL 13 350 P 5/0 LZL 5.5 1x D LZL 6.4 350 300 200 200 230 200 125 250 200 200 8/0 10/0 5/0 6/0 6/0 7/0 8/0 6/0 7/0 8/0 6/0 20 30 45 violet violet undyed multi fi lament 1 PCL + Ca 2 mono fi lament none 12 multi fi lament 1 PCL + Ca 2 12 30 violet multi fi lament 1 PCL + Ca 2 12 45 violet multi fi lament 1 PCL + Ca 2 12 30 violet multi fi lament 1 PCL + Ca 2 12 45 undyed multi fi lament 1 PCL + Ca 2 24 6/0 45 violett multi fi lament 1 PCL + Ca 2 24 P M M, B 10/0 6/0 9/0 10/0 7/0 8/0 8/0 9/0 10/0 6/0 6/0 45 15 30 10 15 45 30 45 30 30 45 45 25 violet multi fi lament 1 PCL + Ca 2 24 violet mono fi lament none undyed multi fi lament 1 PCL + Ca 2 violet mono fi lament none multi fi lament 1 PCL + Ca 2 violet mono fi lament none 12 12 12 violet multi fi lament 1 PCL + Ca 2 12 multi fi lament 1 PCL + Ca 2 12 violet undyed violet undyed violet undyed multi fi lament 1 PCL + Ca 2 12 2x D LZL 6.4 200 2x D LZL 8 300 2x V LZL 8 300 350 B 2x V LZL 8.5 350 5/0 45 6/0 25 violet l e b a b r o s b a A G P ® B R O S A N O Ite m n u m b er G-ON211345 G-ON415575 G-ON415595 G-ON418045 G-ON418056 G-ON347850 G-ON347861 G-ON347870 G-ON347855 G-ON456460 G-ON456470 G-ON351150 G-ON351155 G-ON351156 G-ON351346 G-ON455590 G-ON456450 G-ON456481 G-ON456490 G-ON456465 G-ON456475 G-ON456476 G-ON456485 G-ON456495 G-ON458055 G-ON468055 G-ON468056 G-ON468058 G-ON468155 G-ON468156 G-ON468545 G-ON468546 G-ON468556 1 multifi lament, braided | 2 Polycaprolactone + Calcium stearate 10 ITEM OVERVIEW

® N O L A N O l e b a b r o s b a - n o n Ite m n u m b er G-OL318060 G-OL318045 G-OL415080 G-OL415690 G-OL415695 G-OL144890 G-OL145191 G-OL146470 G-OL146480 G-OL351150 G-OL351160 G-OL351155 G-OL351350 G-OL351630 G-OL351640 G-OL351930 G-OL456280 G-OL456290 G-OL456295 G-OL464895 G-OL466460 N eedle tip (cross-section) N eedle (original size) Arm ed C urvature m) N eedle dia m eter (µ m) N eedle length (m N eedle type Suture U SP Speciality Suture length (c m) Suture color Suture structure C oating Packaging unit 1x 2x 1x 1x 2x 1x 1x H H H H H D D DK DK LZ 8 8 5 230 P 7/0 30 black mono fi lament none 300 100 5/0 30 black mono fi lament none 9/0 20 black mono fi lament none LZL 5.6 150 10/0 15 black mono fi lament none LZL 5.6 150 10/0 30 black mono fi lament none RS RS 5 100 5.1 70 10/0 10/0 10 20 black mono fi lament none black mono fi lament none 1x D RS 6.4 1x D LZL 11 150 140 350 330 8/0 9/0 6/0 7/0 15 black mono fi lament none 45 black mono fi lament none 2x D LZL 11 350 6/0 45 black mono fi lament none 1x D LZL 13 350 6/0 45 black mono fi lament none 1x D LZL 16 430 4/0 5/0 45 black mono fi lament none 1x D LZL 19 530 4/0 45 black mono fi lament none 1x D LZL 6.2 150 9/0 10/0 15 black mono fi lament none 2x 2x 1x D V V LZL 6.2 150 10/0 30 black mono fi lament none LZ 4.8 150 LZL 6.4 200 10/0 7/0 30 30 black mono fi lament none black mono fi lament none 12 12 12 12 12 12 12 12 24 24 24 12 12 12 12 12 12 ITEM OVERVIEW 11

ITEM OVERVIEW N eedle tip (cross-section) N eedle (original size) Arm ed m) N eedle dia m eter (µ m) N eedle length (m N eedle type Suture U SP Speciality C urvature Suture length (c m) Suture color Suture structure C oating 2x D DS 5.6 150 2x D DSL 9.4 1x D DK 7.8 200 230 250 P 200 9/0 6/0 7/0 6/0 7/0 2x D DK 7.8 230 P 7/0 blue monofi lament none blue monofi lament none 30 30 75 45 blue monofi lament none 12 45 75 30 blue monofi lament none blue monofi lament none LZL 5.5 200 10/0 1x 1x D V LZ 19 200 9/0 10 black monofi lament none G-OE461995 2x V LZL 19 200 10/0 20 black monofi lament none 2x ski / S LZ 16 150 10/0 30 blue monofi lament none 1x G RS RS 2x G 2 5 LZL 13 100 100 430 9/0 10/0 10 black monofi lament none 10/0 16 6/0 8 blue monofi lament none 5 Packaging unit 12 12 12 12 12 12 12 12 ® E N E L A N O l e b a b r o s b a - n o n Ite m n u m b er G-OE245685 G-OE249455 G-OE249465 G-OE347850 G-OE347860 G-OE347865 G-OE347866 G-OE455590 G-OE461980 G-OE491695 G-OE172080 G-OE172090 G-OEX1 12 ITEM OVERVIEW

N eedle tip (cross-section) N eedle (original size) Arm ed m) N eedle dia m eter (µ m) N eedle length (m N eedle type Suture U SP Speciality Suture length (c m) Suture color C urvature Suture structure C oating Packaging unit 2x H LZ 8.5 460 350 4/0 5/0 45 white multifi lament 1 NuSil 3 12 Ite m n u m b er G-OB418535 G-OB418545 G-OB341925 2x D DK 19 580 P 3/0 45 green multifi lament 1 NuSil 3 24 ® l e b a b r o s b a - n o n D N O B A N O l e b a b r o s b a - n o n K L I S ® L I F A N O G-OB468535 G-OB468545 G-OB468555 G-OF141630 G-OF141631 G-OF357850 G-OF357860 G-OF357855 G-OF357865 G-OF351150 G-OF351155 G-OF351330 G-OF468545 2x V LZ LZ LZL 8.5 430 350 350 4/0 5/0 6/0 45 white multifi lament 1 NuSil 3 12 1x D RS 16 430 P 4/0 1x D DK 7.8 200 2x D DK 7.8 250 200 LZL 11 300 M 6/0 7/0 6/0 7/0 6/0 50 2x 50 30 45 black multifi lament 1 NuSil 3 24 black multifi lament 1 NuSil 3 12 45 black multifi lament 1 NuSil 3 45 black multifi lament 1 NuSil 3 1x 2x 1x 2x D D D V LZL 11 300 M 6/0 45 black multifi lament 1 NuSil 3 LZL 13 450 M, P 4/0 45 black multifi lament 1 NuSil 3 LZ 8.5 350 5/0 45 black multifi lament 1 NuSil 3 12 24 24 24 12 1 multifi lament, braided | 3 NuSil(R) MED-2174 (NuSil is a registered trademark of Nusil Technology, LLC) ITEM OVERVIEW 13

HIGHLIGHTS BIMANUAL INTRAOCULAR MICRO SUTURE INNOVATIVE MATERIAL AND NEW SUTURING TECHNIQUE BY HATTENBACH (LUDWIGSHAFEN) FOR IOL FIXATION · Re-fi xation of dislocated IOLs without changing the lens / transscleral fi xation · Iris suture / reconstruction · Knot placement and fi xation within the anterior chamber without externalizing the haptic in case of iris trauma or defect · Easy bimanual suture handling with two paracenteses · Small needle size enables spatially fl exible, atraumatic suturing Prof. Dr. Lars-Olof Hattenbach, Chairman Dept. of Ophthalmology, Hospital Ludwigshafen, Germany G-OE172080 ONALENE® PP GRS-2,0-100 9/0, 10 cm, black G-OE172090 ONALENE® PP GRS-2,0-100 10/0, 10 cm, black ONALENE® suture material and Geuder 25G Hattenbach Hybrid Instruments (needle holder, tying forceps and scissors) 14 HIGHLIGHTS

ALL-IN-ONE SOLUTION FOR NON- FILTRATING GLAUCOMA SURGERY ADVANTAGES OF ONALENE® SUTURE PROBE CANALOPLASTY BY KODOMSKOI (OFFENBURG, GERMANY) · Safe and permanent widening of Schlemm‘s canal · Tissue-protecting due to atraumatic tip design · Spiral structure of suture probe enables intraoperative assessment of function and condition of the venous collectors · Easy and solid fi xation of the implant Leonid Kodomskoi Senior Physician at Ortenau Eye Clinic, Offenburg, Germany G-OEX1 ONALENE® PP GRS-5,0-100 10/0, 16 cm, blue ONALENE® PP GLZL-13,0-430 6/0, 8 cm, blue 1 mm ONALENE® 6/0 twisted suture probe (for temporary grip) ONALENE® 10/0 implant (straight thin suture) HIGHLIGHTS 15

THE LABELING CONTAINS ALL IMPORTANT PRODUCT INFORMATION: Product / suture material Suture diameter Suture length ONALON® NYLON BLACK MONOFILAMENT 10-0 USP (0.2metric) 4“ / 10cm LOT LOTCODE YYYY-MM-DD Only STERILE EO OL144890 NON-ABSORBABLE DRS-5.0-100 TAPER POINT 3/8c 5.0mm 12 1 0 0 0 (01)10848782032836 (17)YYMMDD (10)LOTCODE Made in Germany Order number Packaging unit Pieces per box Version number of the label Needle type Needle shape For further information, please visit our Website: https://www.geuder.de/en/products/ suture-materials/ Manufacturer of Onatec suture materials: 2797 FSSB Chirurgische Nadeln GmbH (Jestetten, Germany) 1639 Surgical Specialties Mexico S. de R.L. der C.V. GEUDER AG reserves the right to make changes to technical details in response to recent developments. GEUDER does not assume liability for the accuracy of each individual statement. Illustrations not drawn to scale. GEUDER AG Hertzstrasse 4 69126 Heidelberg Germany Phone: +49 6221 3066 Fax: +49 6221 303122 info@geuder.de www.geuder.com 2 1 4 9 6 3 0 - 1 2 0 2

Cover

Premium surgical sutures

Needle properties

Suture Materials

Specification of suture materials

Application examples of suture materials

ONATEC item overview

Highlights

All in one solution