FDA UDI
In Commercial Distribution
🇺🇸 United States
HANSATON
DI: 07613389143232
·
Model: 058-5227
·
Hansaton Akustik GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- HANSATON
- Primary DI
- 07613389143232
- Version / Model
- 058-5227
- Catalog Number
- 058-5227
- Company Name
- Hansaton Akustik GmbH
- Labeler DUNS
- 316040146
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-12-10
- Public Version
- 3
- Public Version Date
- 2023-11-03
- Public Version Status
- Update
- Public Device Record Key
- 6481b02e-b1d4-44b2-9159-bffc974c80f6
Device Description
USB V3.6.1 Fitting Software Hansaton Scout
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 |
|---|---|---|---|---|
| 60211 | Audiometric/hearing device software | A software program intended to assist with the evaluation of a patient’s hearing capability and/or evaluate and adjust the settings of a hearing assistive device. It may be used by healthcare professionals in a healthcare facility or by the patient in the home, and intended to be used on a non-medical computerized device (e.g., smartphone, tablet). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07613389143232 | GS1 |
Customer Contacts
- Phone
- +49402980110
- [email protected]