Eargo SE

GUDID 00850010429533

Eargo SE System

Eargo, Inc.

Air-conduction hearing aid, in-the-ear
Primary Device ID00850010429533
NIH Device Record Key5071af54-fd94-4ffc-90ad-709270828f5d
Commercial Distribution StatusIn Commercial Distribution
Brand NameEargo SE
Version Model Number99-0155-001
Company DUNS079865289
Company NameEargo, Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
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
GS100850010429533 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QUHSelf-Fitting Air-Conduction Hearing Aid, 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 [Eargo SE]

00850010429625Eargo SE Large Trumpets
00850010429618Eargo SE Medium Trumpets
00850010429601Eargo SE Small Trumpets
00850010429595Eargo SE Additional Charger
00850010429588Eargo SE Additional Cable + Adaptor
00850010429571Eargo SE Replacement Charger
00850010429564Right Eargo SE Hearing Device
00850010429557Left Eargo SE Hearing Device
00850010429533Eargo SE System

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