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Brainlab Elements Object Management
FDA UDIClass II (US FDA UDI)
by Brainlab AG
Identity
- Trade Name
- Brainlab Elements Object Management FDA UDI
- Generic Name
- Radiological PACS software FDA UDI
- Model / Reference
- 1.1 FDA UDI
Identifiers
- Catalog Number
- 21735-02B FDA UDI
- Primary DI / UDI-DI
- 04056481140571 FDA UDI
- 510(k) Number
- K113732 FDA UDI
- FDA Product Code
- LLZ FDA UDIJAK FDA UDI
- GMDN Term
- Radiological PACS software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 FDA UDI892.1750 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Brainlab Elements Object Management by Brainlab AG — 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
- Brainlab AG
Sources (1)
- FDA UDI 79eeb7ea-d99e-407f-8121-132f97ca6b4d 36 fields · synced Jun 8, 2026