Identity
- Trade Name
- RFS Instrument FDA UDI
- Generic Name
- Fluted surgical drill bit, reusable FDA UDI
- Device Name
- RFS™ Pin Drill 2.0mm FDA UDI
- Model / Reference
- RFS-PDR20 FDA UDI
- Description
- RFS™ Pin Drill 2.0mm FDA UDI
Identifiers
- Catalog Number
- RFS-PDR20 FDA UDI
- Primary DI / UDI-DI
- E302RFSPDR209 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Fluted surgical drill bit, 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
Dimensions & Sizes
- Size
- Width — 2.0 Millimeter FDA UDI
The RFS Instrument is a high-performance pin drill designed for orthopedic manual surgical instruments, offering superior precision and accuracy in creating holes in bone. With its unique fluted design and reusable construction, this instrument is ideal for surgeons and medical professionals seeking a reliable tool for various surgical procedures.
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 f2310dba-7b77-48fd-99fb-f83dd36e42b7 37 fields · synced Jul 31, 2026