AXiiiS Stereotactic Miniframe AX-300-01

GUDID 00816589020182

AXiiiS Trajectory Guide

MONTERIS MEDICAL INC

Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system
Primary Device ID00816589020182
NIH Device Record Keya9b4a2bc-e0ae-428d-bb5a-5d689aac970e
Commercial Distribution StatusIn Commercial Distribution
Brand NameAXiiiS Stereotactic Miniframe
Version Model Number20503
Catalog NumberAX-300-01
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 Batchtrue
Serial Numberfalse
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
Emailinfo@monteris.com
Phone+1(866)799-7655
Emailinfo@monteris.com
Phone+1(866)799-7655
Emailinfo@monteris.com
Phone+1(866)799-7655
Emailinfo@monteris.com
Phone+1(866)799-7655
Emailinfo@monteris.com
Phone+1(866)799-7655
Emailinfo@monteris.com
Phone+1(866)799-7655
Emailinfo@monteris.com
Phone+1(866)799-7655
Emailinfo@monteris.com
Phone+1(866)799-7655
Emailinfo@monteris.com
Phone+1(866)799-7655
Emailinfo@monteris.com
Phone+1(866)799-7655
Emailinfo@monteris.com
Phone+1(866)799-7655
Emailinfo@monteris.com
Phone+1(866)799-7655
Emailinfo@monteris.com
Phone+1(866)799-7655
Emailinfo@monteris.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100816589020182 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological Stereotaxic Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-02

Devices Manufactured by MONTERIS MEDICAL INC

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00816589021585 - Mini-Bolt System2024-01-10 NeuroBlate NB3 FullFire™ Diffusing Tip 1.6 Laser Probe
00816589021158 - Mini-Bolt System2023-12-28 1.6mm Mini-Bolt Accessory Kit
00816589021561 - Mini-Bolt System2023-12-28 1.6mm Mini-Bolt and Cap, Sterile Packaged
00816589021578 - Mini-Bolt System2023-12-28 1.6mm Mini-Bolt Accessory Launch Kit
00816589021592 - Mini-Bolt System2023-12-28 1.6mm Mini-Bolt and Cap, Sterile Packaged
00816589021165 - Mini-Bolt System2023-09-18 2.2mm Mini-Bolt VUE Adapter
00816589021172 - Mini-Bolt System2023-09-18 3.3mm Mini-Bolt VUE Adapter
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