Identity
- Trade Name
- WEGO-PGCL Absorbable Surgical Suture With Needle FDA UDI
- Generic Name
- Polyester suture, bioabsorbable, multifilament, non-antimicrobial FDA UDI
- Model / Reference
- A53133-75 EUDAMEDQ63202 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06941813630852 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06941813630852 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
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
A53133-75 is a medical device designed for precise suture placement and application, offering a reliable and effective solution for various medical applications. By providing a detailed overview of its features, compliance, and usage guidelines, this device aims to educate users on how to properly utilize it.
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06941813630852 | 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 1538d6e7-37a3-4466-987c-bc1b5b3095d5 61 fields · synced Oct 6, 2026
- FDA UDI 08be0ef1-8966-4798-88ff-41eec9073dc4 34 fields · synced May 24, 2026