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NeuroBlate NB3 FullFire™ 1.6 Laser Probe

FDA UDI

Class II (US FDA UDI)

by Monteris Medical Corp

Identity

Trade Name
NeuroBlate NB3 FullFire™ 1.6 Laser Probe FDA UDI
Generic Name
MRI-guided laser interstitial thermal therapy system beam guide FDA UDI
Device Name
NeuroBlate NB3 FullFire™ Diffusing Tip 1.6 Laser Probe FDA UDI
Model / Reference
22002 FDA UDI
Description
NeuroBlate NB3 FullFire™ Diffusing Tip 1.6 Laser Probe FDA UDI

Identifiers

Catalog Number
FFD-016 FDA UDI
Primary DI / UDI-DI
00816589021585 FDA UDI
FDA Product Code
GEX FDA UDI
ONO FDA UDI
HAW FDA UDI
GMDN Term
MRI-guided laser interstitial thermal therapy system beam guide FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4810 FDA UDI
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

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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 1.6 Millimeter FDA UDI

Category: MRI-guided laser interstitial thermal therapy system beam guide

NeuroBlate NB3 FullFire™ 1.6 Laser Probe 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 beam guide.

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 f2b51fbe-367c-43d8-849c-fe881698a106 36 fields · synced Jun 8, 2026