Identity
- Trade Name
- Sterile PTFE Surgical Suture FDA UDI
- Generic Name
- Polyolefin/fluoropolymer suture, monofilament FDA UDI
- Device Name
- PTFE SUTURE - HU-FRIEDY - 45 CM - 3/0 CUTTING 16MM 3/8 CIRCLE REVERSE CUTTING FDA UDI
- Model / Reference
- PSNPTFE2 FDA UDI
- Description
- PTFE SUTURE - HU-FRIEDY - 45 CM - 3/0 CUTTING 16MM 3/8 CIRCLE REVERSE CUTTING FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08056646509256 FDA UDI
- FDA Product Code
- NBY FDA UDI
- GMDN Term
- Polyolefin/fluoropolymer suture, monofilament FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.5035 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
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: Polyolefin/fluoropolymer suture, monofilament
Sterile PTFE Surgical Suture by Omnia Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Polyolefin/fluoropolymer suture, monofilament.
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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
- Omnia Spa
Sources (1)
- FDA UDI b711dc4b-96bb-4a11-ac5b-0bc06ae5ea30 35 fields · synced May 30, 2026