AccessGUDID - DEVICE: Cochlear™ Nucleus® 7 Headband (09321502044011)

GUDID

Device Identifier (DI) Information

Brand Name: Cochlear™ Nucleus® 7 Headband
Version or Model: P1335210
Commercial Distribution Status: In Commercial Distribution
Catalog Number: P1335210
Company Name: COCHLEAR LIMITED

Primary DI Number: 09321502044011
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 750551194 *Terms of Use

Device Description: Grey, XSmall

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:	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?
61244	Cochlear implant/auditory brainstem implant sound processor off-ear holder	A device intended to be attached to the sound processor a cochlear implant or auditory brainstem implant system, with an additional clip or other mechanism, to enable the processor to be attached to clothing or other apparel for wearing off-the-ear. It is typically made of synthetic polymer materials. 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	182

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: 822ae5fb-5e7f-42c9-b61e-ded50fcb55ed
Public Version Date: February 19, 2025
Public Version Number: 4
DI Record Publish Date: June 14, 2019