DERMABOND PRINEO Skin Closure System
Ethicon, LLC
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3007791599 | 3007791599 | ETHICON, LLC | 1 | Y | 2026-01-01 | 475 C Street Los Frailes Industrial Park, Suite 401 Guaynabo PR US 00969 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 10705031064669 | MERSILENE - Green Braided Polyester Fiber, Nonabsorbable Surgical Suture | +1(877)384-4266 | xxx@xxx.xxx |
| 10705031064683 | MERSILENE - Green Braided Polyester Fiber, Nonabsorbable Surgical Suture | +1(877)384-4266 | xxx@xxx.xxx |
| 10705031064706 | MERSILENE - Green Braided Polyester Fiber, Nonabsorbable Surgical Suture | +1(877)384-4266 | xxx@xxx.xxx |
| 10705031064805 | MERSILENE - Green Braided Polyester Fiber, Nonabsorbable Surgical Suture | +1(877)384-4266 | xxx@xxx.xxx |
| 10705031064812 | MERSILENE - Green Braided Polyester Fiber, Nonabsorbable Surgical Suture | +1(877)384-4266 | xxx@xxx.xxx |
| 10705031064904 | MERSILENE - Green Braided Polyester Fiber, Nonabsorbable Surgical Suture | +1(877)384-4266 | xxx@xxx.xxx |
| 10705031064959 | MERSILENE - Green Braided Polyester Fiber, Nonabsorbable Surgical Suture | +1(877)384-4266 | xxx@xxx.xxx |
| 10705031064973 | MERSILENE - Green Braided Polyester Fiber, Nonabsorbable Surgical Suture | +1(877)384-4266 | xxx@xxx.xxx |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 105212 | 1015088466 | N18331 | |||
| 105212 | 1132005458 | K964072 | MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED | GAN | 1996-12-18 |
| 105212 | 1775375240 | K963329 | ETHICON ENDOSUTURE SYSTEM | GCJ | 1996-10-25 |
| 105212 | 1415689702 | K960653 | MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED) | GAN | 1996-03-28 |
| 105212 | 1468576920 | K946173 | STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILK | GAQ | 1995-01-09 |
| 105212 | 1035667265 | K843187 | CANNULA | GEA | 1984-10-31 |
| 105212 | 1977178509 | K811872 | TEFLON PLEDGET SUTURE BUTTRESS | DXZ | 1981-08-12 |
| 105212 | 1447601213 | K253852 | MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture | GAM | 2026-02-06 |
| 105212 | 1654699914 | K253572 | STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control Device | GAW | 2026-03-27 |
| 105212 | 1176833096 | K252743 | STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device | GAM | 2025-12-22 |
| 105212 | 1783350191 | K252047 | STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices | NEW | 2026-05-18 |
| 105212 | 1994348240 | K243897 | PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture | NEW | 2025-11-12 |
| 105212 | 1754536009 | K221744 | STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device | GAM | 2022-11-15 |
| 105212 | 1307695332 | K212380 | PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture | NEW | 2022-02-22 |
| 105212 | 1110245899 | K201996 | Monocryl Plus Antibacterial Suture | GAM | 2020-12-21 |
| 105212 | 1457254628 | K192580 | STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device | GAM | 2019-12-18 |
| 105212 | 1013876461 | K192144 | STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device | NEW | 2020-03-25 |
| 105212 | 1245326258 | K183183 | VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable Surgical Suture, PDS Plus Antibacterial Polydioxanone Sterile Synthetic Absorbable Surgical Suture | GAM | 2019-06-27 |
| 105212 | 1463425098 | K182873 | STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Knotless Tissue Control Devices | NEW | 2019-01-10 |
| 105212 | 1853084915 | K181652 | Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture | GAM | 2018-09-28 |
| 105212 | 1594384993 | K170767 | Surgical Stainless Steel Suture, Stainless Steel Suture | GAQ | 2017-11-01 |
| 105212 | 1423297925 | K161726 | E-Pack Procedure Kit | GAM | 2016-07-12 |
| 105212 | 1353980126 | K133356 | PROLENE POLYPROPYLENE NONABSORBABLE SUTURE | GAW | 2013-12-06 |
| 105212 | 1662561931 | K132580 | COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE | GAM | 2014-02-28 |
| 105212 | 1164326715 | K123114 | ETHICON SECURESTRAP OPEN ABSORBABLE STRAP FIXATION DEVICE | GDW | 2013-02-05 |
| 105212 | 1245682482 | K093845 | ETHICON SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE, MODEL STRAP25 | GDW | 2010-04-07 |
| 105212 | 1931629636 | K061037 | PDS PLUS ANTIBACTERIAL SUTURE | NEW | 2006-07-14 |
| 105212 | 1079777302 | K050845 | MONOCRYL PLUS ANTIBACTERIAL SUTURE | GAM | 2005-06-29 |
| 105212 | 1291507364 | K033746 | MODIFIED COATED VICRYL* RAPIDE (POLYGLACTIN 910) SUTURE | GAM | 2003-12-18 |
| 105212 | 1344250849 | K032420 | MODIFIED COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE | GAM | 2003-10-22 |
| 105212 | 1251414255 | K022269 | COATED VICRYL* (POLYGLACTIN 910) SUTURE | GAM | 2002-09-13 |
| 105212 | 1928348946 | ||||
| 105212 | 1951203232 | ||||
| 105212 | 1060784144 | ||||
| 105212 | 1063665612 | ||||
| 105212 | 1141452128 | ||||
| 105212 | 1323293193 |
2026-08-25
2026-08-25
2026-08-25
2026-08-25
2026-08-25
2026-08-25
2026-08-25
2026-08-25
2026-08-25
2026-08-25
2026-08-25
2026-08-25
2026-08-25
2026-08-25
2026-08-25
2026-08-25
2026-08-25
2026-08-25
2026-08-25
2026-08-25
2026-08-25
2026-08-25
2026-08-25
2026-08-25
2026-08-25
2026-08-25
2026-08-25
2026-08-25
2026-08-21
2026-08-21
2026-08-21
2026-08-21
2026-08-21
2026-08-21
2026-08-21
2026-08-21
2015-09-01
2015-09-01
2015-09-01
2015-09-01