Sentiero Advanced
Basic Information
- Brand Name
- Sentiero Advanced
- Primary DI
- 04260223146695
- Version / Model
- 100340-SC-ADT
- Company Name
- PATH medical GmbH
- Labeler DUNS
- 551540334
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-05-19
- Public Version
- 1
- Public Version Date
- 2023-05-29
- Public Version Status
- New
- Public Device Record Key
- 424987c4-d3ec-433a-8fc4-2a8fc93473bd
Device Description
Sentiero Advanced ABR and DPOAE or TEOAE Screening Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3. USB data cable AN100089 4. Path electrodes: 30 pcs. / bag. Each bag contains 10 sets of 3 pcs. AN 100468 5. Sentiero Advanced device with touchscreen AN100360 6. ABR electrode cable AN100307 7. Probe EP-DP Path long AN100028-US 8. Accessory box Sentiero Combo AN100261 9. ABR Quick SW AN100337-Quick 10. DPOAE Quick SW AN100110-Quick or TEOAE Quick SW AN100109-Quick 11. FMDPOAE SW AN100536 (only with AN100110-Quick) 12. Headphone DD45 HP-06 AN100306 13. Mira PC Patient Management SW AN100116 14. Label Printer SW AN100414 15. Power Supply Sentiero Advanced US AN101016+AN100993-USA 16. User Manual Sentiero Senti English AN 100904-EN
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 |
|---|---|---|---|---|
| GWJ | Stimulator, Auditory, Evoked Response | Neurology | 882.1900 | 2 |
| EWO | Audiometer | Ear, Nose, Throat | 874.1050 | 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 | 04260223146695 | GS1 |