Identity
- Trade Name
- McKesson FDA UDI
- Generic Name
- Polyglycolic acid suture FDA UDI
- Device Name
- SUTURE 6-0 Polyglycolic Acid, Undyed, Braided, Coated 6-0 U.S.P. (0.7 Metric) 18"/46cm Synthetic Absorbable Surgical Suture, DSM13 Precision Reverse Cutting 3/8 Circle 13 mm FDA UDI
- Model / Reference
- SJ429G FDA UDI
- Description
- SUTURE 6-0 Polyglycolic Acid, Undyed, Braided, Coated 6-0 U.S.P. (0.7 Metric) 18"/46cm Synthetic Absorbable Surgical Suture, DSM13 Precision Reverse Cutting 3/8 Circle 13 mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20612479189670 FDA UDI
- FDA Product Code
- GAM FDA UDI
- GMDN Term
- Polyglycolic acid suture FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4493 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Polyglycolic acid suture
McKesson by Mckesson Medical-Surgical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Polyglycolic acid suture.
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- MEGASORB — MERIL ENDO SURGERY PRIVATE LIMITED · Class II
- MEGASORB — MERIL ENDO SURGERY PRIVATE LIMITED · Class II
- WEGO-PGA Absorbable Surgical Suture With Needle — Foosin Medical Supplies, Inc. · Class II
- WEGO-PGA Absorbable Surgical Suture With Needle — Foosin Medical Supplies, Inc. · Class II
- WEGO-PGA Absorbable Surgical Suture With Needle — Foosin Medical Supplies, Inc. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Mckesson Medical-Surgical Inc.
Sources (1)
- FDA UDI e835f5c2-6163-4773-a7bc-8939d48a13e2 33 fields · synced Jun 8, 2026