Primary Device ID | 00850010429205 |
NIH Device Record Key | 9f42934e-9e06-4c02-bf8d-4b1c9e2549af |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Eargo RX |
Version Model Number | 99-0177-001 |
Company DUNS | 079865289 |
Company Name | Eargo, Inc. |
Device Count | 1 |
DM Exempt | true |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 1 (855) 690-9360 |
info@eargo.com | |
Phone | 1 (855) 690-9360 |
info@eargo.com | |
Phone | 1 (855) 690-9360 |
info@eargo.com | |
Phone | 1 (855) 690-9360 |
info@eargo.com | |
Phone | 1 (855) 690-9360 |
info@eargo.com | |
Phone | 1 (855) 690-9360 |
info@eargo.com | |
Phone | 1 (855) 690-9360 |
info@eargo.com | |
Phone | 1 (855) 690-9360 |
info@eargo.com | |
Phone | 1 (855) 690-9360 |
info@eargo.com | |
Phone | 1 (855) 690-9360 |
info@eargo.com | |
Phone | 1 (855) 690-9360 |
info@eargo.com | |
Phone | 1 (855) 690-9360 |
info@eargo.com | |
Phone | 1 (855) 690-9360 |
info@eargo.com | |
Phone | 1 (855) 690-9360 |
info@eargo.com | |
Phone | 1 (855) 690-9360 |
info@eargo.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00850010429205 [Primary] |
QDD | Self-Fitting Air-Conduction Hearing Aid, Prescription |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-06-25 |
Device Publish Date | 2024-06-17 |
00850010429274 | Eargo SE-Rx New System |
00850010429205 | Eargo 7-Rx New System |