AccessGUDID - DEVICE: GN Otometrics A/S (05713315000331)

GUDID

Device Identifier (DI) Information

Brand Name: GN Otometrics A/S
Version or Model: Hearing Instrument Programmer
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8-04-14800
Company Name: Natus Medical Denmark ApS

Primary DI Number: 05713315000331
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 306633756 *Terms of Use

Device Description: 1072 HI-PRO 2

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):	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?
61462	Hearing aid/implant system programming interface unit	A portable, electrically-powered device intended to facilitate the wireless or wired connection of a hearing aid or implant system component (e.g., sound processor) to a computer for programming of the hearing device with patient-specific settings and sometimes assessment. It typically consists of a small unit attached to the hearing device. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ESD	Hearing Aid, Air Conduction

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: fad17763-ae44-453f-a25d-34d5b61eaae0
Public Version Date: May 22, 2025
Public Version Number: 7
DI Record Publish Date: September 17, 2016