Identity
- Trade Name
- BodyFIX FDA UDI
- Generic Name
- Vacuum-mould patient positioning system FDA UDI
- Device Name
- The BodyFIX Localizer features three Localizer screens specially designed for stereotactic application. Each of these Localizer screens has three slots with special plastic tubes already inserted. As an alternative to the plastic tubes, these BodyFIX® 14 Localizer Fiducial Set Aluminium contrast rods allow improved visualization in CT. FDA UDI
- Model / Reference
- P10102-227 FDA UDI
- Description
- The BodyFIX Localizer features three Localizer screens specially designed for stereotactic application. Each of these Localizer screens has three slots with special plastic tubes already inserted. As an alternative to the plastic tubes, these BodyFIX® 14 Localizer Fiducial Set Aluminium contrast rods allow improved visualization in CT. FDA UDI
Identifiers
- Catalog Number
- P10102-227 FDA UDI
- Primary DI / UDI-DI
- 04056719000202 FDA UDI
- FDA Product Code
- IYE FDA UDI
- GMDN Term
- Vacuum-mould patient positioning system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5050 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
BodyFIX by 3C-Medical Intelligence GmbH — 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
- 3C-Medical Intelligence GmbH
Sources (1)
- FDA UDI 84888bce-09c0-453a-a360-da2b21f65b01 35 fields · synced Jun 8, 2026