Mini-Bolt System

Basic Information

• Brand Name: Mini-Bolt System
• Primary DI: 00816589021158
• Version / Model: 21224
• Catalog Number: CMB016-AA
• Company Name: MONTERIS MEDICAL INC
• Labeler DUNS: 021415875
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-12-20
• Public Version: 1
• Public Version Date: 2023-12-28
• Public Version Status: New
• Public Device Record Key: cb3fd789-d392-4039-99ae-1752279276f5

Device Description

1.6mm Mini-Bolt Accessory Kit

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HAO	INSTRUMENT, SURGICAL, NON-POWERED	Neurology	882.4535	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32568	Neurological stereotactic surgery system	An 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816589021158	GS1

Device Sizes

Type	Value	Unit	Text
Outer Diameter	1.6	Millimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Away from Sunlight
• Type: Special Storage Condition, Specify
• Special Conditions: Do not use if package is damaged