FDA UDI
In Commercial Distribution
🇺🇸 United States
Phonak Target 11.0
DI: 07613389809190
·
Model: 11.0
·
Sonova AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Phonak Target 11.0
- Primary DI
- 07613389809190
- Version / Model
- 11.0
- Catalog Number
- 088-0125-00110
- Company Name
- Sonova AG
- Labeler DUNS
- 480662550
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-20
- Public Version
- 1
- Public Version Date
- 2025-05-28
- Public Version Status
- New
- Public Device Record Key
- 65fe4f2a-c71a-46b9-be79-33d3fff555b5
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
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| OSM | Hearing Aid, Air-Conduction With Wireless Technology, Prescription | Ear, Nose, Throat | 874.3305 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60112 | Magnetic cell separation system processing unit | A mains electricity (AC-powered) device that is a component of a magnetic cell separation system designed to magnetically separate specific cell types or subpopulations from heterogeneous human cell preparations. It is a programmable device typically consisting of pumping/agitating mechanisms, a magnet, valves, bag hangers and a user display screen. It functions in combination with a magnetizing reagent, a buffered washing solution and a tubing set to separate the target cell population by retention in a magnetic field. The cells are typically used in regenerative medicine (e.g., cardiovascular, haematogenic) or disease treatment (e.g., oncology). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07613389809190 | GS1 |