FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Siemens
DI: 57117810000071
·
Model: UNITY 3 HDA200 HEADSET
·
Ws Audiology Usa, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Siemens
- Primary DI
- 57117810000071
- Version / Model
- UNITY 3 HDA200 HEADSET
- Catalog Number
- 10823937
- Company Name
- Ws Audiology Usa, Inc.
- Labeler DUNS
- 157412271
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-05-08
- Public Version
- 5
- Public Version Date
- 2023-11-17
- Public Version Status
- Update
- Public Device Record Key
- 8a9ad7a5-6153-44da-a482-687835e3f72a
- Distribution End Date
- 2017-04-05
Device Description
Siemens UNITY 3 HDA200 HEADSET
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| EWO | Audiometer | Ear, Nose, Throat | 874.1050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45241 | Audiometric/hearing aid tester | An electroacoustic device intended to be used for both the evaluation of hearing loss (audiometer function) and the evaluation of hearing aids while worn for optimal amplification [real-ear measurement (REM)]; some types may in addition be used to test hearing aid function when being fitted to the patient. It typically consists of a test box and a control unit that connect to an off-the-shelf computer that runs application software to provide results and graphics (which may be stored in a database). It may be used as an audiometer or real-ear-measurement instrument without the test box. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 57117810000071 | GS1 |
Customer Contacts
- Phone
- 17325626600
- [email protected]