AccessGUDID - DEVICE: Cochlear™ Slim Modiolar Electrode Sheath (09321502043564)

GUDID

Device Identifier (DI) Information

Brand Name: Cochlear™ Slim Modiolar Electrode Sheath
Version or Model: P1291522
Commercial Distribution Status: In Commercial Distribution
Catalog Number: P1291522
Company Name: COCHLEAR LIMITED

Primary DI Number: 09321502043564
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 750551194 *Terms of Use

Device Description: N/A

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":	Yes
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?
63161	Cochlear electrode array introducer, single-use	A sterile, hand-held manual surgical instrument designed to aid insertion of an electrode array into the cochlea during implantation of a cochlear implant. It is typically a thin shaft onto which the electrode is distally mounted and then advanced into the cochlea by means of a manually-operated sliding mechanism. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LRC	INSTRUMENT, ENT MANUAL SURGICAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 19d4425d-9fdc-42b4-96ea-059419db4b04
Public Version Date: February 24, 2022
Public Version Number: 2
DI Record Publish Date: January 15, 2019