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NeuroBlate® System

FDA UDI

Class II (US FDA UDI)

by Monteris Medical Corp

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
20980 FDA UDI
Description
NeuroBlate® System FDA UDI

Identifiers

Catalog Number
NB102 FDA UDI
Primary DI / UDI-DI
00816589021080 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
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
MRI Safety
MR Unsafe FDA UDI

Category: MRI-guided laser interstitial thermal therapy system

NeuroBlate® System by Monteris Medical Corp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as MRI-guided laser interstitial thermal therapy system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Monteris Medical Corp

Sources (1)

  • FDA UDI 56b14d71-9abd-4aaa-9d0e-b60838d064b7 35 fields · synced May 30, 2026