AccessGUDID - DEVICE: EARGO (00850010429106)

GUDID

Device Identifier (DI) Information

Brand Name: EARGO
Version or Model: 99-0045-001
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 99-0045-001
Company Name: Eargo, Inc.

Primary DI Number: 00850010429106
Issuing Agency: GS1
Commercial Distribution End Date: September 21, 2022
Device Count: 6
Labeler D-U-N-S® Number*: 079865289 *Terms of Use

Device Description: EARGO Replacement Flexi Fiber, Size Large

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?
60543	Hearing aid wax guard	A device intended to shield the sound outlet of a hearing aid receiver (speaker) to prevent debris (e.g., wax, sweat) from entering. It typically consists of a plastic or metal perforated cover or gauze that may be changed periodically. Attachment and removal device may be included.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ESD	Hearing aid, air conduction

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: 596905e0-462a-4e58-94ba-85a621e67730
Public Version Date: March 21, 2023
Public Version Number: 3
DI Record Publish Date: October 14, 2019