Link by Eargo

GUDID 00850010429656

Link by Eargo Small Eartips (Open & Closed)

Eargo, Inc.

Air-conduction hearing aid, in-the-ear
Primary Device ID00850010429656
NIH Device Record Keyf76878f7-9a88-4ca0-9cab-b8c0f8391aa3
Commercial Distribution StatusIn Commercial Distribution
Brand NameLink by Eargo
Version Model Number99-0174-001
Company DUNS079865289
Company NameEargo, Inc.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100850010429656 [Primary]

FDA Product Code

QUGHearing Aid, Air-Conduction With Wireless Technology, Over The Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-06
Device Publish Date2024-01-29

On-Brand Devices [Link by Eargo]

00850010429670Link by Eargo Large Eartips (Open & Closed)
00850010429663Link by Eargo Medium Eartips (Open & Closed)
00850010429656Link by Eargo Small Eartips (Open & Closed)
00850010429649Link by Eargo

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