Identity
- Trade Name
- WEGO-PGCL Absorbable Surgical Suture With Needle FDA UDI
- Generic Name
- Polyester suture, bioabsorbable, multifilament, non-antimicrobial FDA UDI
- Model / Reference
- A47173-75 EUDAMEDQB009001 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06941813630869 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06941813630869 EUDAMED
- 510(k) Number
- K142810 FDA UDI
- FDA Product Code
- GAM FDA UDI
- EMDN Code
- H010101020202 POLYGLYCOLIC WITH LACTIC ACID MULTIFILAMENT WITH NEEDLE FOR VIDEO SURGERY EUDAMED
- GMDN Term
- Polyester suture, bioabsorbable, multifilament, non-antimicrobial FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4493 FDA UDI
- Market of Registration
- France 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
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
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
A47173-75 by Foosin Medical Supplies Inc., 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
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06941813630869 | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Foosin Medical Supplies Inc., Ltd.
- EUDAMED SRN
- CN-MF-000006957
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED 01b3b16c-132e-4609-aa35-a0f367040507 61 fields · synced Oct 6, 2026
- FDA UDI 99d85475-9e61-4125-908e-6d4e517f70a8 34 fields · synced May 30, 2026