FDA UDI
In Commercial Distribution
🇺🇸 United States
Sentiero Diagnostic
DI: 04260223145360
·
Model: 100250-US2-T
·
PATH medical GmbH
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Sentiero Diagnostic
- Primary DI
- 04260223145360
- Version / Model
- 100250-US2-T
- Company Name
- PATH medical GmbH
- Labeler DUNS
- 551540334
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-27
- Public Version
- 1
- Public Version Date
- 2020-07-06
- Public Version Status
- New
- Public Device Record Key
- 206e08d7-083e-4c9d-829b-81d85157f7e8
Device Description
Sentiero Diagnostic TEOAE Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3. USB data cable AN100089 4. Sentiero Diagnostic device with touchscreen AN100098 5. Probe EP-DP Path long AN100028-US 6. TEOAE Software AN100109 7. Software label printer AN100414 8. PC based Patient Management, Mira Software: Patient data & result transfer from instrument to PC, reporting options, export functions, printing via PC, data archive for Windows 10, Windows 7 etc. AN100116 9. Accessory box Sentiero Combo AN100261 10. Power supply Sentiero US AN101013+AN100993-USA
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| EWO | Audiometer | Ear, Nose, Throat | 874.1050 | 2 |
| GWJ | Stimulator, Auditory, Evoked Response | Neurology | 882.1900 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35747 | Evoked-potential audiometer | An electroacoustic instrument designed to evaluate the activity of the auditory pathway of the brain in response to an acoustic signal [auditory brainstem response (ABR)] it provides at the ear (e.g., clicks delivered through an earphone), without need of patient cooperation. The signal, detected via the device's scalp electrodes and possibly a reference electrode on the ear lobe, is measured using computer averaging and signal processing techniques. This device is typically used to assess the function of the auditory pathways and to differentiate coma due to metabolic factors from structural damage. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04260223145360 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K133012 | 000 |