FDA UDI In Commercial Distribution 🇺🇸 United States

Link by Eargo

DI: 00850010429670 · Model: 99-0174-003 · Eargo, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Link by Eargo
Primary DI
00850010429670
Version / Model
99-0174-003
Company Name
Eargo, Inc.
Labeler DUNS
079865289
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2024-01-29
Public Version
1
Public Version Date
2024-02-06
Public Version Status
New
Public Device Record Key
a221e72c-9543-48fb-affb-5cff00e9b3b0

Device Description

Link by Eargo Large Eartips (Open & Closed)

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
Yes
PM Exempt
Yes
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
QUG Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter

GMDN Terms

Code Name
34672 Air-conduction hearing aid, in-the-ear

Identifiers

Type ID
Primary 00850010429670