AccessGUDID - DEVICE: Soundwave Hearing (00850016231291)

GUDID

Device Identifier (DI) Information

Brand Name: Soundwave Hearing
Version or Model: 991011-SWH
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Soundwave Hearing, LLC

Primary DI Number: 00850016231291
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 050441605 *Terms of Use

Device Description: OPEN-MEDIUM/991011-SWH; 10-pc blister pack of replacement ear domes for RIC used on Sontro Self-Fitting OTC Hearing Aids

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?
62259	Earmould, preformed	A preformed device designed to fit in an ear canal and through which the acoustic output from a hearing aid is conveyed to the eardrum. It is made of soft synthetic polymer materials and may have various forms (e.g., plug-like, ear shape). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QUH	Self-Fitting Air-Conduction Hearing Aid, Over The Counter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 788115ea-4305-4c29-aa98-2a4a553b9669
Public Version Date: November 09, 2023
Public Version Number: 3
DI Record Publish Date: November 01, 2021