AccessGUDID - DEVICE: Cochlear™ Microphone Cover (09321502066846)

GUDID

Device Identifier (DI) Information

Brand Name: Cochlear™ Microphone Cover
Version or Model: P1878196
Commercial Distribution Status: In Commercial Distribution
Catalog Number: P1878196
Company Name: COCHLEAR LIMITED

Primary DI Number: 09321502066846
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 750551194 *Terms of Use

Device Description: Sand

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
61242	Cochlear implant/auditory brainstem implant coil cover/spacer	A small device intended to be used as a cover/cap for the coil of a cochlear implant (CI) or auditory brainstem implant system, and/or to maintain the position of the coil casing. It is typically supplied with a removal tool. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MCM	Implant, cochlear

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P970051	211

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
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: f292c619-d3d6-4fb4-aaf3-867771b2fd30
Public Version Date: December 07, 2022
Public Version Number: 1
DI Record Publish Date: November 29, 2022