Magnet Insertion Tool

Basic Information

• Brand Name: Magnet Insertion Tool
• Primary DI: 09008737083991
• Version / Model: 08399
• Catalog Number: 09734
• Company Name: Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
• Labeler DUNS: 300764032
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-02-27
• Public Version: 5
• Public Version Date: 2022-09-14
• Public Version Status: Update
• Public Device Record Key: 7012e95e-4914-4995-bbb9-3db6554bffb8

Device Description

Reusable Surgical Tool

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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
MCM	IMPLANT, COCHLEAR	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
62564	Cochlear implant implantable magnet inserter/remover	A hand-held manual surgical instrument designed to aid insertion, reinsertion and/or removal of the subcutaneous magnet component of a cochlear implant system. It is made of high-grade stainless steel and is in a form suited for its application. This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09008737083991	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P000025	079