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Disposable Kit For Cirq With Robotic Alignment Module
FDA UDIEUDAMEDClass II (US FDA UDI)
by Brainlab SE
Identity
- Trade Name
- DISPOSABLE KIT FOR CIRQ WITH ROBOTIC ALIGNMENT MODULE FDA UDI
- Generic Name
- Surgical instrument assist arm system, power-adjusted FDA UDI
- Model / Reference
- 56101 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056481141660 FDA UDI
- FDA Product Code
- OLO FDA UDIHAW FDA UDI
- GMDN Term
- Surgical instrument assist arm system, power-adjusted FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Disposable Kit For Cirq With Robotic Alignment Module by Brainlab SE — Class II — 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 II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Brainlab SE
Sources (2)
- FDA UDI e030f358-9b0b-4174-ab8b-1f06f132dae0 34 fields · synced Jun 17, 2026
- EUDAMED 1 fields · synced Jun 2, 2026