Identity
- Trade Name
- UNISILK V EUDAMEDFDA UDI
- Generic Name
- Silk suture FDA UDI
- Device Name
- Sterile Single Use Natural Non-Absorbable Surgical Suture with or without needle EUDAMEDVirgin Silk, Natural Non-Absorbable Surgical Sututres / Ligatures FDA UDI
- Model / Reference
- UNISILK V EUDAMEDSD2007 EUDAMEDFDA UDI
- Description
- Virgin Silk, Natural Non-Absorbable Surgical Sututres / Ligatures FDA UDI
Identifiers
- Catalog Number
- SD2007 FDA UDI
- Primary DI / UDI-DI
- 06285379076137 EUDAMED16285379148886 FDA UDI
- Basic UDI-DI
- B-06285379076137 EUDAMED
- 510(k) Number
- K042282 FDA UDI
- FDA Product Code
- GAP FDA UDI
- EMDN Code
- H010202020301,H010202020302 EUDAMED
- GMDN Term
- Silk suture FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 878.5030 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 0.04 Millimeter FDA UDI
Unisilk V by United Medical Industries Co. Ltd — Class III — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
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-06285379076137 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-06285379076137 | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- United Medical Industries Co. Ltd
- EUDAMED SRN
- SA-MF-000004541
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 4cf2ccf0-9ffd-4473-a7a3-d88c87d76a93 61 fields · synced May 31, 2026
- FDA UDI 80cf920a-1ae1-4c48-959d-b45943954783 38 fields · synced May 30, 2026