Eargo RX

GUDID 00850010429274

Eargo SE-Rx New System

Eargo, Inc.

Air-conduction hearing aid, in-the-ear
Primary Device ID00850010429274
NIH Device Record Keyc2887a5d-29bd-43ba-9fd4-f8a37efc52ee
Commercial Distribution StatusIn Commercial Distribution
Brand NameEargo RX
Version Model Number99-0178-001
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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100850010429274 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QDDSelf-Fitting Air-Conduction Hearing Aid, Prescription

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-25
Device Publish Date2024-06-17

On-Brand Devices [Eargo RX]

00850010429274Eargo SE-Rx New System
00850010429205Eargo 7-Rx New System

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