AccessGUDID - DEVICE: SONNET 3 BabyWear Kit (DL) Black (09008737385842)

GUDID

Device Identifier (DI) Information

Brand Name: SONNET 3 BabyWear Kit (DL) Black
Version or Model: 38584
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Med-El Elektromedizinische Geräte Gesellschaft m.b.H.

Primary DI Number: 09008737385842
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 300764032 *Terms of Use

Device Description: Audio Processor Accessory

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:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
62943	Cochlear implant system external kit	A collection of non-sterile devices intended to be given to a cochlear implant patient, typically after the first fitting, as a convenience kit of various external components of a cochlear implant system. It typically includes a cochlear implant sound processor and associated devices such as a coil, coil cable, external magnet, remote control, batteries, and battery holder.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MCM	Implant, Cochlear

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P000025	000

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: 4730481e-f637-428a-afc5-de2d20437acf
Public Version Date: March 07, 2025
Public Version Number: 1
DI Record Publish Date: February 27, 2025