AccessGUDID - DEVICE: Magnet Insertion Tool (09008737083991)

GUDID

Device Identifier (DI) Information

Brand Name: Magnet Insertion Tool
Version or Model: 08399
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 09734
Company Name: Med-El Elektromedizinische Geräte Gesellschaft m.b.H.

Primary DI Number: 09008737083991
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 300764032 *Terms of Use

Device Description: Reusable Surgical Tool

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MCM	IMPLANT, COCHLEAR

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P000025	079

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7012e95e-4914-4995-bbb9-3db6554bffb8
Public Version Date: September 14, 2022
Public Version Number: 5
DI Record Publish Date: February 27, 2015