AccessGUDID - DEVICE: TOMORE (06977275990036)

GUDID

Device Identifier (DI) Information

Brand Name: TOMORE
Version or Model: OTC, Behind-THE-EAR Hearing Aid
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Tomore Healthcare (Dongguan) Co.,Ltd.

Primary DI Number: 06977275990036
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 844874890 *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):	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?
62260	Air-conduction hearing aid acoustic tube	A small tubular detachable device designed to conduct sound waves from an air-conduction hearing aid [e.g., behind-the-ear (BTE)] to an earmould to convey acoustic output to the eardrum. It is made of soft synthetic polymer materials. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QUF	Hearing Aid, Air-Conduction, Over The Counter

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: 9445824e-61f1-4e70-bde7-37adf59f0daf
Public Version Date: November 29, 2024
Public Version Number: 1
DI Record Publish Date: November 21, 2024