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Reference Array Drill Guide 4 Markers
FDA UDIClass II (US FDA UDI)
by Brainlab AG
Identity
- Trade Name
- Reference Array Drill Guide 4 Markers FDA UDI
- Generic Name
- Robotic surgical navigation system FDA UDI
- Model / Reference
- 56203-01 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056481140427 FDA UDI
- 510(k) Number
- K183605 FDA UDI
- FDA Product Code
- OLO FDA UDI
- GMDN Term
- Robotic surgical navigation system 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
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Reference Array Drill Guide 4 Markers 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 a9c9bb61-8305-42f7-9229-bd1fa2fe62cc 35 fields · synced Jun 6, 2026