FDA.reportPublic FDA data

Mini-Bolt System

Primary DI
00816589021172
Brand
Mini-Bolt System
Company
MONTERIS MEDICAL INC
Model
21239
Catalog number
CMB033-VA
Device description
3.3mm Mini-Bolt VUE Adapter
Published
2023-09-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HAOINSTRUMENT, SURGICAL, NON-POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAOInstrument, Surgical, Non-PoweredNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816589021172PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816589021172008165890211728165890211720816589021172

GMDN Terms#

Term, Definition table
TermDefinition
Neurological stereotactic surgery systemAn assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during neurosurgery. The system may include computerized functions to store diagnostic images used for image-guided surgery.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter3.3Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Away from Sunlight

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021415875
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816589021608Mini-Bolt Accessory Kit21180CMB000-AA2026-02-23
00816589021219Fiducial Marker, Sterile212512025-02-07
00816589021202Mini-Bolt System29008CMB016-AA-R2024-11-12
00816589021226Mini-Bolt System21247CMB-ST2024-08-08
00816589021196Mini-Bolt System21155CMBVUE-UP2024-05-20
00816589021585NeuroBlate NB3 FullFire™ 1.6 Laser Probe22002FFD-0162024-01-02
00816589021189Mini-Bolt System21228CMB-VX2024-03-21
00816589021158Mini-Bolt System21224CMB016-AA2023-12-20
00816589021561Mini-Bolt System21165CMB016-S2023-12-20
00816589021578Mini-Bolt System21209CMB016-UP2023-12-20
00816589021592Mini-Bolt System22004CMB016-MS2023-12-20
00816589021165Mini-Bolt System21237CMB022-VA2023-09-10
00816589021240AtamA System20648ASA0012022-12-14
00816589021257Mini-Bolt System20755CMB0222022-12-14
00816589021264Mini-Bolt System20820208202022-12-14
00816589021271Mini-Bolt System20821208212022-12-14
00816589021288Mini-Bolt System21065210652022-12-14
00816589021295Mini-Bolt System20802208022022-12-14
00816589021301Mini-Bolt System21154CMB022-AA-R2022-12-14
00816589021318Mini-Bolt System21153CMB033-AA-R2022-12-14

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