FDA UDI
In Commercial Distribution
🇺🇸 United States
Phonak Brand
DI: 07613389393101
·
Model: 050-0770-0090
·
Sonova AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Phonak Brand
- Primary DI
- 07613389393101
- Version / Model
- 050-0770-0090
- Catalog Number
- 050-0770-0090
- Company Name
- Sonova AG
- Labeler DUNS
- 480662550
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-22
- Public Version
- 2
- Public Version Date
- 2020-11-06
- Public Version Status
- Update
- Public Device Record Key
- 5d72091a-522c-4d72-99a0-402c706cf060
Device Description
Phonak Audéo P90-13T
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 |
|---|---|---|---|---|
| OSM | Hearing aid, air conduction with wireless technology | Ear, Nose, Throat | 874.3305 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47170 | Superficial skin exfoliant, home-use | A substance applied to the surface of the skin for the chemical removal of the superficial cells of the epidermis (desquamation) typically to remove wrinkles, acne, acne scars, pigmentations, and other skin pathologies for dermatological and/or aesthetic purposes; it is not intended to treat corns or calluses. It typically includes as active ingredients acids (e.g., salicylic, glycolic, citric, malic, alpha hydroxy, beta hydroxy) and/or enzymes (e.g., fruit). It is available [non-prescription] over-the-counter (OTC) as a gel or liquid solution for use in the home and healthcare facility. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07613389393101 | GS1 |
Customer Contacts
- Phone
- +41589280101
- [email protected]