AccessGUDID - DEVICE: Siemens (04046355373082)

GUDID

Device Identifier (DI) Information

Brand Name: Siemens
Version or Model: UNITY 2 USER MANUAL AUDIOMETRY
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 10419008
Company Name: Ws Audiology Usa, Inc.

Primary DI Number: 04046355373082
Issuing Agency: GS1
Commercial Distribution End Date: April 05, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 157412271 *Terms of Use

Device Description: Siemens UNITY 2 USER MANUAL AUDIOMETRY

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):	Yes
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?
45241	Audiometric/hearing aid tester	An electroacoustic device intended to be used for both the evaluation of hearing loss (audiometer function) and the evaluation of hearing aids while worn for optimal amplification [real-ear measurement (REM)]; some types may in addition be used to test hearing aid function when being fitted to the patient. It typically consists of a test box and a control unit that connect to an off-the-shelf computer that runs application software to provide results and graphics (which may be stored in a database). It may be used as an audiometer or real-ear-measurement instrument without the test box.	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: 7aaed8cb-b025-47d3-a628-146cbda214de
Public Version Date: November 17, 2023
Public Version Number: 5
DI Record Publish Date: May 08, 2016