Identity
- Trade Name
- Premium UNIFY Plain Gut Sutures FDA UDI
- Generic Name
- Catgut suture, plain FDA UDI
- Device Name
- Premium UNIFY Plain Gut Sutures Med 4-0, 19mm 3/8 Circle Rev Cut, 27" FDA UDI
- Model / Reference
- PMJ-427R19 FDA UDI
- Description
- Premium UNIFY Plain Gut Sutures Med 4-0, 19mm 3/8 Circle Rev Cut, 27" FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814639022919 FDA UDI
- 510(k) Number
- K000542 FDA UDI
- FDA Product Code
- GAL FDA UDI
- GMDN Term
- Catgut suture, plain FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4830 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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: Catgut suture, plain
Premium UNIFY Plain Gut Sutures by Applied Dental, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K000542 also covers:
- Premium UNIFY Chromic Sutures — APPLIED DENTAL, INC.
- Premium UNIFY Chromic Sutures — APPLIED DENTAL, INC.
- Premium UNIFY Chromic Sutures — APPLIED DENTAL, INC.
- Premium UNIFY Fast Plain Gut Sutures — APPLIED DENTAL, INC.
- Premium UNIFY Fast Plain Gut Sutures — APPLIED DENTAL, INC.
- Premium UNIFY Fast Plain Gut Sutures — APPLIED DENTAL, INC.
- Premium UNIFY Plain Gut Sutures — APPLIED DENTAL, INC.
- Premium UNIFY Plain Gut Sutures — APPLIED DENTAL, INC.
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 c16a6612-1d2c-46fe-9034-073efd8947e4 35 fields · synced Jun 8, 2026