MEDINAUT MAX

Basic Information

• Brand Name: MEDINAUT MAX
• Primary DI: 08800038053137
• Version / Model: BMA-R30
• Company Name: IMEDICOM CO., LTD.
• Labeler DUNS: 690340653
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-01-12
• Public Version: 1
• Public Version Date: 2022-01-20
• Public Version Status: New
• Public Device Record Key: 7cf84d2e-5137-47d5-b745-0a8ad8539b51
• Distribution End Date: 2022-01-12

Device Description

BMA-R30_AO Large Reamer Attachment

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• 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
KIJ	Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment	General, Plastic Surgery	878.4820	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44641	Multi-purpose surgical power tool system, rechargeable battery-powered	An assembly of devices designed to resect bones and tough tissues (e.g., cartilage, ligaments) during a surgical procedure; it is not dedicated to a specific clinical application. It includes a rechargeable battery pack/control unit which supplies low-voltage electricity, motors/handpieces/power tool attachments, and a variety of tools (e.g., drill bits, burs, saw blades, screwdriver bits, and guide wires); it is not intended to be connected to mains power.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08800038053137	GS1