Identity
- Trade Name
- UNIFY Cable Nylon Sutures FDA UDI
- Generic Name
- Nylon suture, non-bioabsorbable, monofilament FDA UDI
- Device Name
- Cable Nylon, MED 3-0, 19mm 3/8 Rev Cut, 18". 12 pcs/bx. White. FDA UDI
- Model / Reference
- M-V318R19 FDA UDI
- Description
- Cable Nylon, MED 3-0, 19mm 3/8 Rev Cut, 18". 12 pcs/bx. White. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814639022278 FDA UDI
- FDA Product Code
- GAR FDA UDI
- GMDN Term
- Nylon suture, non-bioabsorbable, monofilament FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.5020 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
Yes
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
UNIFY Cable Nylon Sutures by Applied Dental, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 248e1be3-3373-4469-856f-32df31992008 35 fields · synced Jun 8, 2026