Identity
- Trade Name
- NeuroBlate® System FDA UDI
- Generic Name
- MRI-guided laser interstitial thermal therapy system FDA UDI
- Device Name
- NeuroBlate® System FDA UDI
- Model / Reference
- 20720 FDA UDI
- Description
- NeuroBlate® System FDA UDI
Identifiers
- Catalog Number
- NB102-R FDA UDI
- Primary DI / UDI-DI
- 00816589020649 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- MRI-guided laser interstitial thermal therapy system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 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
MR Unsafe FDA UDI
NeuroBlate® System by Monteris Medical Corp — 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
- Monteris Medical Corp
Sources (1)
- FDA UDI 2de70db9-2848-4e52-a7dc-1d5ecfd94710 36 fields · synced Jun 8, 2026