AccessGUDID - DEVICE: SND TE+DPOAE Newborn (UGD probe with 8-pin probe adaptor) (05060396170355)

GUDID

Device Identifier (DI) Information

Brand Name: SND TE+DPOAE Newborn (UGD probe with 8-pin probe adaptor)
Version or Model: PR-SND
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OTODYNAMICS LIMITED

Primary DI Number: 05060396170355
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 235908050 *Terms of Use

Device Description: No description.

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?
58018	Otoacoustic emission system, line-powered	An assembly of mains electricity (AC-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 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 [?]
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: 90cd48b2-28a1-4487-9786-467eb3f45f69
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: July 15, 2016