FDA UDI In Commercial Distribution 🇺🇸 United States

hear.com

DI: 05714880225860 · Model: HORIZON Go 3 IX · Ws Audiology Usa, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
hear.com
Primary DI
05714880225860
Version / Model
HORIZON Go 3 IX
Catalog Number
21035715
Company Name
Ws Audiology Usa, Inc.
Labeler DUNS
157412271
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2024-02-09
Public Version
1
Public Version Date
2024-02-19
Public Version Status
New
Public Device Record Key
36963f34-455a-4344-9c8f-8f2c6b5879eb

Device Description

HA HORIZON GO 3 IX SB

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
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
No
PM Exempt
Yes
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
OSM Hearing Aid, Air-Conduction With Wireless Technology, Prescription

GMDN Terms

Code Name
47169 Air-conduction hearing aid, receiver-in-canal

Identifiers

Type ID
Primary 05714880225860

Customer Contacts

Phone
17325626600