Identity
- Trade Name
- Buzz 2.0 FDA UDI
- Generic Name
- Medical image management system FDA UDI
- Model / Reference
- 15800 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056481140977 FDA UDI
- FDA Product Code
- OUG FDA UDILMD FDA UDI
- GMDN Term
- Medical image management system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6310 FDA UDI892.2020 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Buzz 2.0 by Brainlab AG — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Brainlab AG
Sources (1)
- FDA UDI 7bce637f-805c-4200-b988-4fac4ee0b831 34 fields · synced Jun 8, 2026