AccessGUDID - DEVICE: GN Hearing (05708296137220)

GUDID

Device Identifier (DI) Information

Brand Name: GN Hearing
Version or Model: 517-002-000-02
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Gn Hearing A/S

Primary DI Number: 05708296137220
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 306179227 *Terms of Use

Device Description: EYEGLASS CROS UNIT BCE-4, BN

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):	No
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?
59460	Contralateral hearing unit	A passive (i.e., non-powered) acoustic device intended to compensate for total hearing loss in one ear, by transmitting sound received by a microphone from the deaf ear to an active (i.e., powered) hearing aid worn on the hearing ear. This contralateral routing of sound (CROS) technology is designed to improve awareness of sounds (e.g., traffic, speech) emanating from all directions. The device typically consists of a microphone contained in a case worn behind-the-ear (BTE) with a connection cable. The cable both transmits the power from, and the signal to, the active hearing aid.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OSM	Hearing aid, air conduction with wireless technology

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: 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: 1d7ad3d8-271d-46e5-a64f-e0173a08d9b9
Public Version Date: August 23, 2018
Public Version Number: 1
DI Record Publish Date: July 23, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1-888-735-4327
Email: consumerhelp@gnresound.com

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