FDA UDI
In Commercial Distribution
🇺🇸 United States
Desyncra For Tinnitus Therapy System
DI: EDYGTI1004EU01
·
Model: Size XL
·
Desyncra Operating GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Desyncra For Tinnitus Therapy System
- Primary DI
- EDYGTI1004EU01
- Version / Model
- Size XL
- Catalog Number
- TI10.04EU_01
- Company Name
- Desyncra Operating GmbH
- Labeler DUNS
- 313625455
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-03-02
- Public Version
- 2
- Public Version Date
- 2018-07-06
- Public Version Status
- New
- Public Device Record Key
- af04ca69-6f2d-408c-a765-5931769e7eba
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
- 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 | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KLW | Masker, Tinnitus | Ear, Nose, Throat | 874.3400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38049 | Tinnitus masking application software | An individual software application program or group of programs, routines or algorithms designed for use in, or together with, other devices such as a computer, a digital hearing aid, or formated into a compact disc read-only memory (CD-ROM) or an MP3 format to enable it to provide generated noise of sufficient intensity and bandwidth to mask (make less noticeable and provide temporary relief from) tinnitus (a ringing sound in the ear or internal head noises). The basic set of applications programs and routines can be upgraded to add new system capabilities. Application program packages are typically identified by a proprietary name and "version" or "upgrade" number. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | EDYGTI1004EU01 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K151558 | 000 |