FDA UDI In Commercial Distribution 🇺🇸 United States

Signia

DI: 05714880210279 · Model: KIT Silk C&G 3IX · Ws Audiology Usa, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Signia
Primary DI
05714880210279
Version / Model
KIT Silk C&G 3IX
Catalog Number
21026948
Company Name
Ws Audiology Usa, Inc.
Labeler DUNS
157412271
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-09-14
Public Version
1
Public Version Date
2023-09-22
Public Version Status
New
Public Device Record Key
5ca33be2-1d48-4fd1-a3bc-402e36cb27a3

Device Description

KIT Silk C&G 3IX TRANSPARENT

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
KLW Masker, Tinnitus

GMDN Terms

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

Identifiers

Type ID
Primary 05714880210279

Customer Contacts

Phone
17325626600