Identity
- Trade Name
- UNIFY Stainless Surgical Sutures FDA UDI
- Generic Name
- Metallic suture, monofilament FDA UDI
- Device Name
- Stainless Steel Suture Size 4, 48mm 1/2 Cir T/P, 18". 2 pcs/pack FDA UDI
- Model / Reference
- W4D-18T48 FDA UDI
- Description
- Stainless Steel Suture Size 4, 48mm 1/2 Cir T/P, 18". 2 pcs/pack FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814639025040 FDA UDI
- FDA Product Code
- GAQ FDA UDI
- GMDN Term
- Metallic suture, monofilament FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4495 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: Metallic suture, monofilament
UNIFY Stainless Surgical Sutures by Applied Dental, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Myo/Wire II — A & E MEDICAL CORPORATION · 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
- Applied Dental, Inc.
Sources (1)
- FDA UDI 7bc149f8-586b-41f9-9767-01c39d51e59f 34 fields · synced May 30, 2026