Mini-Bolt System CMB016-UP

GUDID 00816589021578

1.6mm Mini-Bolt Accessory Launch Kit

MONTERIS MEDICAL INC

Neurological stereotactic surgery system
Primary Device ID00816589021578
NIH Device Record Keyb500e4ac-8beb-4337-a30e-61a458857e57
Commercial Distribution StatusIn Commercial Distribution
Brand NameMini-Bolt System
Version Model Number21209
Catalog NumberCMB016-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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Outer Diameter1.6 Millimeter
Outer Diameter1.6 Millimeter
Outer Diameter1.6 Millimeter
Outer Diameter1.6 Millimeter
Outer Diameter1.6 Millimeter
Outer Diameter1.6 Millimeter
Outer Diameter1.6 Millimeter
Outer Diameter1.6 Millimeter
Outer Diameter1.6 Millimeter
Outer Diameter1.6 Millimeter
Outer Diameter1.6 Millimeter
Outer Diameter1.6 Millimeter
Outer Diameter1.6 Millimeter
Outer Diameter1.6 Millimeter
Outer Diameter1.6 Millimeter
Outer Diameter1.6 Millimeter
Outer Diameter1.6 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged

Device Identifiers

Device Issuing AgencyDevice ID
GS100816589021578 [Primary]

FDA Product Code

HAOINSTRUMENT, SURGICAL, NON-POWERED

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816589021578]

Moist Heat or Steam Sterilization


[00816589021578]

Moist Heat or Steam Sterilization


[00816589021578]

Moist Heat or Steam Sterilization


[00816589021578]

Moist Heat or Steam Sterilization


[00816589021578]

Moist Heat or Steam Sterilization


[00816589021578]

Moist Heat or Steam Sterilization


[00816589021578]

Moist Heat or Steam Sterilization


[00816589021578]

Moist Heat or Steam Sterilization


[00816589021578]

Moist Heat or Steam Sterilization


[00816589021578]

Moist Heat or Steam Sterilization


[00816589021578]

Moist Heat or Steam Sterilization


[00816589021578]

Moist Heat or Steam Sterilization


[00816589021578]

Moist Heat or Steam Sterilization


[00816589021578]

Moist Heat or Steam Sterilization


[00816589021578]

Moist Heat or Steam Sterilization


[00816589021578]

Moist Heat or Steam Sterilization


[00816589021578]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-28
Device Publish Date2023-12-20

On-Brand Devices [Mini-Bolt System]

008165890211723.3mm Mini-Bolt VUE Adapter
008165890211652.2mm Mini-Bolt VUE Adapter
008165890215921.6mm Mini-Bolt and Cap, Sterile Packaged
008165890215781.6mm Mini-Bolt Accessory Launch Kit
008165890215611.6mm Mini-Bolt and Cap, Sterile Packaged
008165890211581.6mm Mini-Bolt Accessory Kit
00816589021585NeuroBlate NB3 FullFire™ Diffusing Tip 1.6 Laser Probe
00816589021189VUE Extractor Tool
00816589021196Mini-Bolt VUE Accessory Kit
00816589021226Stryker Precision Targeting System - 4.5mm Drill Guide, Packaged
008165890212021.6mm Mini-Bolt Accessory Kit, Refurbished

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