AccessGUDID - DEVICE: Interacoustics (05711117227529)

GUDID

Device Identifier (DI) Information

Brand Name: Interacoustics
Version or Model: Equinox Evo
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Interacoustics A/S

Primary DI Number: 05711117227529
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 306308354 *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?
63545	Vestibulo-auditory analysis system	An assembly of devices designed to assess the function of the auditory and vestibular systems using multiple vestibulo-auditory parameters which include audiometry (e.g., air, bone, speech), tympanometry, auditory evoked-potential (AEP) [e.g., auditory brainstem response (ABR)], otoacoustic emission (OAE), auditory steady-state response (ASSR), and vestibular evoked myogenic potential (VEMP). It includes a console which may be connected to an off-the-shelf computer, devices used for the transmission of stimuli and reception of electrical signals generated by the patient (e.g., preamplifier, audiometric ear tips, electrodes), and dedicated software. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EWO	Audiometer

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: 7ea5bae4-49a7-4ed1-a6a8-a111d4ffab37
Public Version Date: March 25, 2025
Public Version Number: 1
DI Record Publish Date: March 17, 2025

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: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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