FDA UDI
In Commercial Distribution
🇺🇸 United States
Phonak Brand
DI: 07613389392654
·
Model: 054-0953
·
Sonova AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Phonak Brand
- Primary DI
- 07613389392654
- Version / Model
- 054-0953
- Catalog Number
- 054-0953
- Company Name
- Sonova AG
- Labeler DUNS
- 480662550
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-12-27
- Public Version
- 1
- Public Version Date
- 2021-01-04
- Public Version Status
- New
- Public Device Record Key
- 5209e9a9-51da-4823-bdc7-5093d21b1395
Device Description
Lyric SoundLync kit
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
- MR Unsafe
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| ESD | Hearing aid, air conduction | Ear, Nose, Throat | 874.3300 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57885 | Hearing aid/implant system remote control | A battery-powered device designed to be operated by the wearer of a hearing aid or a hearing implant system to enable discreet wireless (remote) adjustments to the device (e.g., volume and program changes). It is designed to be conveniently portable (e.g., carried in a pocket, handbag, or attached to a key ring). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07613389392654 | GS1 |
Customer Contacts
- Phone
- +41589280101
- [email protected]