← Back to catalogue
Sterilization Tray Hip Replacement
FDA UDIEUDAMEDClass I (US FDA UDI)
by Brainlab SE
Identity
- Trade Name
- STERILIZATION TRAY HIP REPLACEMENT FDA UDI
- Generic Name
- Device sterilization/disinfection container, reusable FDA UDI
- Model / Reference
- 52309 FDA UDI
Identifiers
- Catalog Number
- 52309 FDA UDI
- Primary DI / UDI-DI
- 04056481122812 FDA UDI
- FDA Product Code
- FSM FDA UDI
- GMDN Term
- Device sterilization/disinfection container, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Sterilization Tray Hip Replacement by Brainlab SE — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Brainlab SE
Sources (2)
- FDA UDI 4ffb981f-1ac3-4d3b-bfba-9fcc393c8171 35 fields · synced Jun 17, 2026
- EUDAMED 1 fields · synced May 29, 2026