Identity
- Trade Name
- Flux-C Cervical Interbody FDA UDI
- Generic Name
- Bone file/rasp, manual, reusable FDA UDI
- Device Name
- Rasp, 19x16mm, 8mm height, 12-degree FDA UDI
- Model / Reference
- UU082-62-1916-08 FDA UDI
- Description
- Rasp, 19x16mm, 8mm height, 12-degree FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810076336312 FDA UDI
- FDA Product Code
- ODP FDA UDI
- GMDN Term
- Bone file/rasp, manual, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 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
No
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
Category: Bone file/rasp, manual, reusable
Flux-C Cervical Interbody by Ulrich Medical Usa, Inc. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Ulrich Medical Usa, Inc.
Sources (1)
- FDA UDI b8c760e4-db03-489d-8db3-c3bbb51bdc86 34 fields · synced Jun 7, 2026