Identity
- Trade Name
- RFS Instrument FDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- RFS™ Driver Insert 2.5mm FDA UDI
- Model / Reference
- RFS-DI25 FDA UDI
- Description
- RFS™ Driver Insert 2.5mm FDA UDI
Identifiers
- Catalog Number
- RFS-DI25 FDA UDI
- Primary DI / UDI-DI
- E302RFSDI259 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Surgical screwdriver, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
RFS Instrument by Bioretec Oy — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Bioretec Oy
Sources (1)
- FDA UDI bcf259aa-debe-4d2f-b6b9-e50a8c770daf 36 fields · synced May 31, 2026