FDA UDI In Commercial Distribution 🇺🇸 United States

hear.com

DI: 04056839109243 · Model: horizon 7X RIC · Ws Audiology Usa, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
hear.com
Primary DI
04056839109243
Version / Model
horizon 7X RIC
Catalog Number
10969907
Company Name
Ws Audiology Usa, Inc.
Labeler DUNS
157412271
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-10-06
Public Version
2
Public Version Date
2023-12-08
Public Version Status
Update
Public Device Record Key
662814df-b9f1-40ca-b2aa-3be8dd309e40

Device Description

horizon 7X RIC Sandy Brown (31)

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
KLW Masker, Tinnitus

GMDN Terms

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

Identifiers

Type ID
Primary 04056839109243

Customer Contacts

Phone
17325626600