Eargo 6

GUDID 00850010429366

Eargo 6 System

Eargo, Inc.

Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear
Primary Device ID00850010429366
NIH Device Record Key695eb3eb-353e-4baa-a034-93c4250bd728
Commercial Distribution StatusIn Commercial Distribution
Brand NameEargo 6
Version Model Number99-0147-001
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1 (855) 690-9360
Emailinfo@eargo.com
Phone1 (855) 690-9360
Emailinfo@eargo.com
Phone1 (855) 690-9360
Emailinfo@eargo.com
Phone1 (855) 690-9360
Emailinfo@eargo.com
Phone1 (855) 690-9360
Emailinfo@eargo.com
Phone1 (855) 690-9360
Emailinfo@eargo.com
Phone1 (855) 690-9360
Emailinfo@eargo.com
Phone1 (855) 690-9360
Emailinfo@eargo.com
Phone1 (855) 690-9360
Emailinfo@eargo.com
Phone1 (855) 690-9360
Emailinfo@eargo.com
Phone1 (855) 690-9360
Emailinfo@eargo.com
Phone1 (855) 690-9360
Emailinfo@eargo.com
Phone1 (855) 690-9360
Emailinfo@eargo.com
Phone1 (855) 690-9360
Emailinfo@eargo.com
Phone1 (855) 690-9360
Emailinfo@eargo.com
Phone1 (855) 690-9360
Emailinfo@eargo.com
Phone1 (855) 690-9360
Emailinfo@eargo.com
Phone1 (855) 690-9360
Emailinfo@eargo.com
Phone1 (855) 690-9360
Emailinfo@eargo.com
Phone1 (855) 690-9360
Emailinfo@eargo.com
Phone1 (855) 690-9360
Emailinfo@eargo.com
Phone1 (855) 690-9360
Emailinfo@eargo.com
Phone1 (855) 690-9360
Emailinfo@eargo.com
Phone1 (855) 690-9360
Emailinfo@eargo.com
Phone1 (855) 690-9360
Emailinfo@eargo.com
Phone1 (855) 690-9360
Emailinfo@eargo.com
Phone1 (855) 690-9360
Emailinfo@eargo.com
Phone1 (855) 690-9360
Emailinfo@eargo.com
Phone1 (855) 690-9360
Emailinfo@eargo.com
Phone1 (855) 690-9360
Emailinfo@eargo.com
Phone1 (855) 690-9360
Emailinfo@eargo.com
Phone1 (855) 690-9360
Emailinfo@eargo.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850010429366 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OSMHearing Aid, Air Conduction With Wireless Technology
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 Date2021-12-29
Device Publish Date2021-12-21

On-Brand Devices [Eargo 6]

00850010429373Eargo 6 Right HI
00850010429366Eargo 6 System
00850010429359Eargo 6 Left HI
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