FDA UDI
In Commercial Distribution
🇺🇸 United States
Unitron Brand
DI: 07613389528084
·
Model: 050-6473-R8
·
Sonova AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Unitron Brand
- Primary DI
- 07613389528084
- Version / Model
- 050-6473-R8
- Company Name
- Sonova AG
- Labeler DUNS
- 480662550
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-06-10
- Public Version
- 1
- Public Version Date
- 2022-06-21
- Public Version Status
- New
- Public Device Record Key
- 332c66bd-23d4-4cae-8e9d-a92958849c07
Device Description
Moxi B3-RS Right (sand)
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
- 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 |
|---|---|---|---|---|
| OSM | Hearing Aid, Air Conduction With Wireless Technology | Ear, Nose, Throat | 874.3305 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41769 | Immunoglobulin A subclass (IgA subclass) IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of one or multiple immunoglobulin A subclasses (IgA subclasses) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07613389528084 | GS1 |