AccessGUDID - DEVICE: Insertion Electrode FLEXsoft (09008737082550)

GUDID

Device Identifier (DI) Information

Brand Name: Insertion Electrode FLEXsoft
Version or Model: 08255
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Med-El Elektromedizinische Geräte Gesellschaft m.b.H.

Primary DI Number: 09008737082550
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 300764032 *Terms of Use

Device Description: Insertion Electrode

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:	Yes
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?
61603	Cochlear electrode array depth gauge, single-use	A hand-held manual surgical instrument intended to be used during insertion of an electrode array into the cochlea during implantation of a cochlear implant, to determine the number of active bands that can be implanted, to measure insertion depth, and sometimes to assess cochlear lumen patency. It consists of a thin probe with depth markings mounted on a handle, made of metal [e.g., platinum (Pt)] and synthetic polymers (e.g., silicone). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MCM	Implant, Cochlear

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P000025	094

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store the sterilized contents in this box at room temperature until the stated expiry date.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 71a6b2c5-fce0-45e2-af5b-86aa1616dbfc
Public Version Date: May 17, 2023
Public Version Number: 8
DI Record Publish Date: April 19, 2018