Identity
- Trade Name
- GIBSON FDA UDI
- Generic Name
- Polytetrafluoroethylene suture FDA UDI
- Device Name
- suture 4-0 PTFE 18" PS-2 BX12 FDA UDI
- Model / Reference
- 5067-689 FDA UDI
- Description
- suture 4-0 PTFE 18" PS-2 BX12 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00366975002259 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
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: Polytetrafluoroethylene suture
Gibson by Benco Dental Supply Co. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polytetrafluoroethylene suture.
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- CYTOSURG — RIVERPOINT MEDICAL LLC · Class II
- PTFE — RIVERPOINT MEDICAL LLC · Class II
- MONOTEX — RIVERPOINT MEDICAL LLC · Class II
- Maxima — HENRY SCHEIN, INC. · Class II
- Maxima — HENRY SCHEIN, INC. · 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
- Benco Dental Supply Co.
Sources (1)
- FDA UDI cec386ca-5fea-447a-9fb6-c9db2464302f 33 fields · synced Jun 8, 2026