AccessGUDID - DEVICE: OtoNova Pro Clinical+TE (05060396173486)

GUDID

Device Identifier (DI) Information

Brand Name: OtoNova Pro Clinical+TE
Version or Model: NPRO-CLN-DT
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OTODYNAMICS LIMITED

Primary DI Number: 05060396173486
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 235908050 *Terms of Use

Device Description: OtoNova Pro system for Clinical OAE hearing test applications. Includes OtoNova Pro instrument, ear probe, system items, and Clinical licence for the Nova-link app

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?
58019	Otoacoustic emission system, battery-powered	An assembly of battery-powered devices designed to record and analyse the faint sounds hair cells in the inner ear emit [otoacoustic emission (OAE)] in response to a stimulus (e.g., click, tone burst, pure-tone signals) to test for a deficiency of function in the ear during diagnostic evaluation and/or neonatal screening. It typically consists of a portable programmable unit, an OAE probe, and eartips. The stimulus signal is emitted via the probe inserted into the ear canal and the response is recorded via a microphone in the probe; OAEs are absent/reduced in patients with hearing loss. The system may be combined with other audiological devices (e.g., tympanometer, ABR device).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EWO	Audiometer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K234095	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: 1601db39-1639-40a8-8163-398b2785181d
Public Version Date: August 28, 2024
Public Version Number: 1
DI Record Publish Date: August 20, 2024