Identity
- Trade Name
- Navigated Brain Biopsy Cannula FDA UDI
- Generic Name
- Brain biopsy procedure kit FDA UDI
- Device Name
- Navigate Brain Biopsy Cannula - Compatible BrainLab FDA UDI
- Model / Reference
- BL3000 FDA UDI
- Description
- Navigate Brain Biopsy Cannula - Compatible BrainLab FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815212020285 FDA UDI
- 510(k) Number
- K140705 FDA UDI
- FDA Product Code
- HAW FDA UDI
- GMDN Term
- Brain biopsy procedure kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Brain biopsy procedure kit
Navigated Brain Biopsy Cannula by Izi Medical Products Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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
- Izi Medical Products Llc
Sources (1)
- FDA UDI d00634c0-ccca-47a0-b066-258ca34963b9 34 fields · synced Jun 8, 2026