Identity
- Trade Name
- WEGO-SILK Non-absorbable Surgical Suture With Needle FDA UDI
- Generic Name
- Silk suture FDA UDI
- Model / Reference
- S33183-75 EUDAMEDS53163-45 EUDAMEDS1007510 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06941813650102 EUDAMEDFDA UDI
- Basic UDI-DI
- 69418136NA-suturesIIbS83 EUDAMED
- Direct Marketing DI
- 06941813650102 EUDAMED
- 510(k) Number
- K080684 FDA UDI
- FDA Product Code
- GAP FDA UDI
- EMDN Code
- H010202020301 SILK WITH NEEDLE EUDAMED
- GMDN Term
- Silk suture FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.5030 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- Not 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
Sutures
Yes
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
Yes
FDA UDI
S53163-45 by Foosin Medical Supplies Inc., Ltd. — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69418136NA-suturesIIbS83 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Foosin Medical Supplies Inc., Ltd.
- EUDAMED SRN
- CN-MF-000006957
- Authorised Representative
- MedNet EC-REP C III GmbH DE-AR-000011196
Sources (2)
- EUDAMED ccdb5f3e-0f51-4e10-b7d2-9c32ec04269c 61 fields · synced Jun 18, 2026
- FDA UDI be47a684-3332-4e78-b00f-b917fe530f1f 34 fields · synced May 30, 2026