Mini-Bolt VUE Accessory Kit CMBVUE-UP

GUDID 00816589021141

Mini-Bolt VUE Accessory Kit

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
Primary Device ID00816589021141
NIH Device Record Keyf63213b3-995a-4a24-a63b-99697789ff51
Commercial Distribution StatusIn Commercial Distribution
Brand NameMini-Bolt VUE Accessory Kit
Version Model Number21155
Catalog NumberCMBVUE-UP
Company DUNS021415875
Company NameMONTERIS MEDICAL INC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
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
Emailjhoneck@monteris.com
Phone+1(866)799-7655
Emailjhoneck@monteris.com
Phone+1(866)799-7655
Emailjhoneck@monteris.com
Phone+1(866)799-7655
Emailjhoneck@monteris.com
Phone+1(866)799-7655
Emailjhoneck@monteris.com
Phone+1(866)799-7655
Emailjhoneck@monteris.com
Phone+1(866)799-7655
Emailjhoneck@monteris.com
Phone+1(866)799-7655
Emailjhoneck@monteris.com
Phone+1(866)799-7655
Emailjhoneck@monteris.com

Device Dimensions

Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter6 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100816589021141 [Primary]

FDA Product Code

HAOINSTRUMENT, SURGICAL, NON-POWERED

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816589021141]

Moist Heat or Steam Sterilization


[00816589021141]

Moist Heat or Steam Sterilization


[00816589021141]

Moist Heat or Steam Sterilization


[00816589021141]

Moist Heat or Steam Sterilization


[00816589021141]

Moist Heat or Steam Sterilization


[00816589021141]

Moist Heat or Steam Sterilization


[00816589021141]

Moist Heat or Steam Sterilization


[00816589021141]

Moist Heat or Steam Sterilization


[00816589021141]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-02
Device Publish Date2022-07-25

Devices Manufactured by MONTERIS MEDICAL INC

00816589021189 - Mini-Bolt System2024-03-29 VUE Extractor Tool
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.