AccessGUDID - DEVICE: Baha 5 SuperPower Earhook 2+ (S) (09321502051415)

GUDID

Device Identifier (DI) Information

Brand Name: Baha 5 SuperPower Earhook 2+ (S)
Version or Model: P1173606
Commercial Distribution Status: In Commercial Distribution
Catalog Number: P1173606
Company Name: Cochlear Bone Anchored Solutions AB

Primary DI Number: 09321502051415
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 559784736 *Terms of Use

Device Description: Retention device to hold Baha 5 SuperPower sound processor in Under-the-Ear position (UTE)

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:	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?
58511	Direct acoustic cochlear implant system	A battery-powered assembly of devices [direct acoustic cochlear implant (DACI)] intended to compensate for severe to profound mixed hearing loss by direct acoustical stimulation of the cochlea. It consists of an implanted receiver/stimulator (electronic assembly) connected to a transducer and a behind-the-ear (BTE) or at the head (button) sound processor consisting of a microphone(s), electronics, batteries, coil, and coil cable. The sound processor transmits an electric signal to the implant, via a radio-frequency link, where the signal is processed and passed to the transducer which converts the signal into vibrations that drive the perilymph inside the cochlea.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LXB	Hearing aid, bone conduction

FDA Premarket Submission

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

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: 03487760-77ea-4aba-b9b1-7aa95243cf08
Public Version Date: January 27, 2025
Public Version Number: 4
DI Record Publish Date: February 26, 2020