FDA UDI In Commercial Distribution 🇺🇸 United States

Desyncra For Tinnitus Therapy System

DI: EDSYTI1002EU01 · Model: Size M · DESYNCRA TINNITUS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Desyncra For Tinnitus Therapy System
Primary DI
EDSYTI1002EU01
Version / Model
Size M
Catalog Number
TI10.02EU_01
Company Name
DESYNCRA TINNITUS LIMITED
Labeler DUNS
220194467
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-06-12
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
81391449-135a-40b7-a50b-49fca02efa5a

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
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
No
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
KLW Masker, Tinnitus

GMDN Terms

Code Name
38049 Tinnitus masking application software

Identifiers

Type ID
Primary EDSYTI1002EU01