Identity
- Trade Name
- OPTILENE FDA UDI
- Generic Name
- Polyolefin/fluoropolymer suture, monofilament FDA UDI
- Device Name
- OPTILENE 0 (3,5) 75CM HS48 (M)RCP FDA UDI
- Model / Reference
- C3095329 FDA UDI
- Description
- OPTILENE 0 (3,5) 75CM HS48 (M)RCP FDA UDI
Identifiers
- Catalog Number
- C3095329 FDA UDI
- Primary DI / UDI-DI
- 04046964794827 FDA UDI
- FDA Product Code
- GAW FDA UDI
- GMDN Term
- Polyolefin/fluoropolymer suture, monofilament FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.5010 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
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
Dimensions & Sizes
- Size
- Length — 75.0 Centimeter FDA UDI
Optilene by B Braun Surgical Sa — 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
- B Braun Surgical Sa
Sources (1)
- FDA UDI 0cde6fbc-ae78-4f54-ac64-47e63fa09de3 37 fields · synced May 31, 2026