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NeuroBlate Optic SideFire® Laser Probe

FDA UDI

Class II (US FDA UDI)

by Monteris Medical Corp

Identity

Trade Name
NeuroBlate Optic SideFire® Laser Probe FDA UDI
Generic Name
MRI-guided laser interstitial thermal therapy system beam guide FDA UDI
Device Name
3.3mm Directional Laser Probe FDA UDI
Model / Reference
20891-4 FDA UDI
Description
3.3mm Directional Laser Probe FDA UDI

Identifiers

Catalog Number
NBP-401-01 FDA UDI
Primary DI / UDI-DI
00816589020922 FDA UDI
FDA Product Code
GEX 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
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

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 Conditional FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 3.3 Millimeter FDA UDI

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

NeuroBlate Optic SideFire® 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 61be656a-a40d-405f-bf66-3f71e4ead0b6 36 fields · synced May 30, 2026