NeuroBlate Optic FullFire® Laser Probe FFS222-01

GUDID 00816589021042

2.2mm Diffusing Tip Laser Probe

MONTERIS MEDICAL INC

MRI-guided laser interstitial thermal therapy system beam guide
Primary Device ID00816589021042
NIH Device Record Keyb4687f21-0907-4d8c-9e52-8a6c8acf434e
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeuroBlate Optic FullFire® Laser Probe
Version Model Number20895-2
Catalog NumberFFS222-01
Company DUNS021415875
Company NameMONTERIS MEDICAL INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(866)799-7655
Emailgglaser@monteris.com
Phone+1(866)799-7655
Emailgglaser@monteris.com
Phone+1(866)799-7655
Emailgglaser@monteris.com

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS100816589021042 [Primary]

FDA Product Code

GEXPowered laser surgical instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-11-19
Device Publish Date2018-10-17

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