AccessGUDID - DEVICE: External Talk Through Microphone (00817020020372)

GUDID

Device Identifier (DI) Information

Brand Name: External Talk Through Microphone
Version or Model: M025550
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: INTELLIGENT HEARING SYSTEMS CORP.

Primary DI Number: 00817020020372
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 154870455 *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):	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?
36768	Freestanding microphone	A freestanding electroacoustic transducer designed to capture sound waves, usually vocal, and convert them into electrical signals that are amplified typically for various medical communication/recording or patient-assistive applications. It is not permanently attached to or integrated into another device and may operate via wireless technology. It is typically hand held, attached to clothing, or placed in a holder.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EWO	Audiometer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K900096	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: 4b81804b-907e-4a8c-807f-144aa8b77814
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016