Identity
- Trade Name
- PTFE FDA UDI
- Generic Name
- Polytetrafluoroethylene suture FDA UDI
- Device Name
- Suture FDA UDI
- Model / Reference
- 5067-652 FDA UDI
- Description
- Suture FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00812444025880 FDA UDI
- FDA Product Code
- NBY FDA UDI
- GMDN Term
- Polytetrafluoroethylene suture 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
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
No
FDA UDI
Category: Polytetrafluoroethylene suture
Ptfe by Riverpoint Medical Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polytetrafluoroethylene suture.
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- C-PTFE — Cp Medical · Class II
- Golnit PTFE Suture — Golnit Sutures · Class II
- StitchKit — Origami Surgical, LLC · Class II
- Golnit PTFE Suture — Golnit Sutures · 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
- Riverpoint Medical Llc
Sources (1)
- FDA UDI 511ad856-58dc-43ea-b3e3-ad3b0f23dac6 33 fields · synced May 31, 2026