Eargo 7

GUDID 00850010429427

Right Eargo 7 Hearing Device

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
Primary Device ID00850010429427
NIH Device Record Key10f2b173-3204-4277-b797-e5109caedc0e
Commercial Distribution StatusIn Commercial Distribution
Brand NameEargo 7
Version Model Number99-0158-001
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
GS100850010429427 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OSMHearing Aid, Air-Conduction With Wireless Technology, Prescription
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 Date2023-03-28
Device Publish Date2023-03-20

On-Brand Devices [Eargo 7]

00850010429427Right Eargo 7 Hearing Device
00850010429410Left Eargo 7 Hearing Device
00850010429403Eargo 7 System
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