AccessGUDID - DEVICE: GN Otometrics A/S (05713315002854)

GUDID

Device Identifier (DI) Information

Brand Name: GN Otometrics A/S
Version or Model: ELECTR LD, SNAP, 24 IN, BLACK
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Natus Medical Denmark ApS

Primary DI Number: 05713315002854
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 306633756 *Terms of Use

Device Description: No description.

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?
35368	Auditory stimulator	A mains electricity (AC-powered) device that applies sound stimuli (e.g., pure tones, speech) to a patient's acoustic system. It is typically used as a component of several types of devices such as audiometers, auditory evoked-potential recording systems, and auditory function screening devices.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GWJ	Stimulator, Auditory, Evoked Response

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K083399	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: aa23d0d9-5d8f-43d6-b5be-f37d9e98dc41
Public Version Date: April 18, 2025
Public Version Number: 5
DI Record Publish Date: September 20, 2016