DEVICE: EARGO (00850010429106)
Device Identifier (DI) Information
EARGO
99-0045-001
Not in Commercial Distribution
99-0045-001
Eargo, Inc.
99-0045-001
Not in Commercial Distribution
99-0045-001
Eargo, Inc.
EARGO Replacement Flexi Fiber, Size Large
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
60543 | Hearing aid wax guard |
A device intended to shield the sound outlet of a hearing aid receiver (speaker) to prevent debris (e.g., wax, sweat) from entering. It typically consists of a plastic or metal perforated cover or gauze that may be changed periodically. Attachment and removal device may be included.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
ESD | Hearing aid, air conduction |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
596905e0-462a-4e58-94ba-85a621e67730
March 21, 2023
3
October 14, 2019
March 21, 2023
3
October 14, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
10850010429103
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1 (855) 690-9360
info@eargo.com
info@eargo.com