Identity
- Trade Name
- Fixone Instrument FDA UDI
- Generic Name
- Fluted surgical drill bit, single-use FDA UDI
- Device Name
- This product is a medical cutting tool that is used in connection with an electric medical handpiece to make holes in the bone for implantation of bone screws. It is compatible with other bone screws having a shaft diameter of less than 1.6mm FDA UDI
- Model / Reference
- Fixone.I.JF-D/B180 FDA UDI
- Description
- This product is a medical cutting tool that is used in connection with an electric medical handpiece to make holes in the bone for implantation of bone screws. It is compatible with other bone screws having a shaft diameter of less than 1.6mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800039102209 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Fluted surgical drill bit, single-use 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
No
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Fluted surgical drill bit, single-use
Fixone Instrument by Aju Pharm. Co., Ltd. — 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
- Aju Pharm. Co., Ltd.
Sources (1)
- FDA UDI d4097787-6f34-4c15-9fd3-86b8befd54e5 33 fields · synced May 30, 2026