Identity
- Trade Name
- BREMER HIFIX FDA UDI
- Generic Name
- Cervical spine immobilization system, single-use FDA UDI
- Device Name
- BREMER CROWN & RING ACCESSORY SYSTEM W/HIFIX LARGE CROWN 23-26 in. (58-66 cm) FDA UDI
- Model / Reference
- HT036HI FDA UDI
- Description
- BREMER CROWN & RING ACCESSORY SYSTEM W/HIFIX LARGE CROWN 23-26 in. (58-66 cm) FDA UDI
Identifiers
- Catalog Number
- HT036HI FDA UDI
- Primary DI / UDI-DI
- 10705034341965 FDA UDI
- 510(k) Number
- K915800 FDA UDI
- FDA Product Code
- JEC FDA UDI
- GMDN Term
- Cervical spine immobilization system, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Bremer Hifix by Depuy Spine, Inc. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Depuy Spine, Inc.
Sources (1)
- FDA UDI 46c4e86a-659e-4a00-bf55-916c6429f9a7 37 fields · synced May 29, 2026