AccessGUDID - DEVICE: hearX (00860003469828)

GUDID

Device Identifier (DI) Information

Brand Name: hearX
Version or Model: hearScope
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HEARX GROUP (PTY) LTD

Primary DI Number: 00860003469828
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 539177681 *Terms of Use

Device Description: hearScope consists of a handheld video otoscope with a light source and ear speculum of various sizes that connects to an Android smartphone (can be user-supplied).

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):	Yes
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?
12849	Otoscope, direct	An electrically-powered, hand-held device designed for examination of the outer ear canal and tympanic membrane (eardrum) by direct viewing through the ear opening. It consists of a main unit (commonly referred to as the head) with a built-in light source intended to illuminate the interior of the ear canal with a detachable cone-shaped tube (speculum) inserted in the ear canal; it may facilitate the application of air pressure for pneumatic otoscopy. A dedicated power supply handpiece and/or an insufflation bulb may be included with the head.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ERA	Otoscope

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: Yes

Sterilization Method [?]
High-level Disinfectant

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: 3a062b74-2e58-4fca-8783-9d232ef4b43b
Public Version Date: June 07, 2022
Public Version Number: 1
DI Record Publish Date: May 30, 2022