Desyncra For Tinnitus Therapy System
- Primary DI
- EDSYTI1002EU01
- Brand
- Desyncra For Tinnitus Therapy System
- Company
- DESYNCRA TINNITUS LIMITED
- Model
- Size M
- Catalog number
- TI10.02EU_01
- Published
- 2017-06-12
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| KLW | Masker, Tinnitus |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| KLW | Masker, Tinnitus | Ear, Nose, Throat | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| EDSYTI1002EU01 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| 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. |
Regulatory Flags
- DUNS number
- 220194467
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| EDSYTI1001EU01 | Desyncra For Tinnitus Therapy System | Size S | TI10.01EU_01 | 2017-06-12 |
| EDSYTI1003EU01 | Desyncra For Tinnitus Therapy System | Size L | TI10.03EU_01 | 2017-06-12 |
| EDSYTI1004EU01 | Desyncra For Tinnitus Therapy System | Size XL | TI10.04EU_01 | 2017-06-12 |
Other Devices Sharing Product Codes