Identity
- Trade Name
- UNIFY PGCL Surgical Sutures FDA UDI
- Generic Name
- Poliglecaprone suture FDA UDI
- Device Name
- PGCL, Absorbable, Med, 4-0, 16mm 3/8 Circle, Conventional Cut, 18" Undyed. FDA UDI
- Model / Reference
- M-Q418A16 FDA UDI
- Description
- PGCL, Absorbable, Med, 4-0, 16mm 3/8 Circle, Conventional Cut, 18" Undyed. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814639022490 FDA UDI
- FDA Product Code
- GAM FDA UDI
- GMDN Term
- Poliglecaprone 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
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Poliglecaprone suture
UNIFY PGCL Surgical Sutures by Applied Dental, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Applied Dental, Inc.
Sources (1)
- FDA UDI 39a6bedb-e5b0-4cb7-a897-2b5032ae10c8 34 fields · synced May 31, 2026