Identity
- Trade Name
- 8.0MM Flexible Reamer FDA UDI
- Generic Name
- Cannulated surgical drill bit, reusable FDA UDI
- Device Name
- A surgical drilling instrument (8.0mm diameter) intended to be connected to a standard power tool, which is used to open and enlarge the medullary canal for the insertion of the CurvaFix IM Implant during a fracture fixation procedure. This device is cannulated so that it can be fed over a guiding wire that has been placed into the correct position inside the bone prior to operation of the drill. FDA UDI
- Model / Reference
- CFR-080 FDA UDI
- Description
- A surgical drilling instrument (8.0mm diameter) intended to be connected to a standard power tool, which is used to open and enlarge the medullary canal for the insertion of the CurvaFix IM Implant during a fracture fixation procedure. This device is cannulated so that it can be fed over a guiding wire that has been placed into the correct position inside the bone prior to operation of the drill. FDA UDI
Identifiers
- Catalog Number
- CFR-080 FDA UDI
- Primary DI / UDI-DI
- 10855068008294 FDA UDI
- FDA Product Code
- HTO FDA UDI
- GMDN Term
- Cannulated surgical drill bit, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- 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
- Outer Diameter — 8.0 Millimeter FDA UDI
Category: Cannulated surgical drill bit, reusable
8.0MM Flexible Reamer by Curvafix Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Curvafix Inc
Sources (1)
- FDA UDI eda8cc83-6f96-4070-b7d3-6b020a8691ef 36 fields · synced May 30, 2026