Identity
- Trade Name
- ETHIBOND; DURAKNOT EUDAMEDFDA UDI
- Generic Name
- Polyester suture, non-bioabsorbable, multifilament FDA UDI
- Device Name
- Endosuture System Reload Units for Suture Assistant With Ethibond EXCEL Green Braided Polyester Suture FDA UDI
- Model / Reference
- SW120 EUDAMEDFDA UDI
- Description
- Endosuture System Reload Units for Suture Assistant With Ethibond EXCEL Green Braided Polyester Suture FDA UDI
Identifiers
- Catalog Number
- SW120 FDA UDI
- Primary DI / UDI-DI
- D-USMF000013107000038ML EUDAMED10705036002918 FDA UDI
- Basic UDI-DI
- B-USMF000013107000038ML EUDAMED
- FDA Product Code
- GCJ FDA UDI
- EMDN Code
- H02010101 SKIN STAPLERS, SINGLE-USE EUDAMED
- GMDN Term
- Polyester suture, non-bioabsorbable, multifilament FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ethibond +1 more model by Ethicon Endo-Surgery, LLC — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — 2 models — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-USMF000013107000038ML | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Ethicon Endo-Surgery, LLC
- EUDAMED SRN
- US-MF-000013107
- Authorised Representative
- Johnson & Johnson Medical GmbH DE-AR-000007712
Sources (2)
- EUDAMED d042ed49-a47a-410e-a46b-98fbee25cd9b 61 fields · synced Jun 19, 2026
- FDA UDI 5be55fdf-e70e-4632-85bd-05261d116140 35 fields · synced May 30, 2026