Duns Number:551540334
Device Description: Sentiero Advanced ABR and TEOAE Screening SetContent:1. Case AN1005032. Inlay Sentiero AN1 Sentiero Advanced ABR and TEOAE Screening SetContent:1. Case AN1005032. Inlay Sentiero AN1006773. USB data cable AN1000894. Path electrodes: 30 pcs. / bag. Each bag contains 10 sets of 3 pcs. AN 1004685. Sentiero Advanced device with touchscreen AN1003606. ABR electrode cable AN1003077. Probe EP-DP Path long AN100028-US8. Accessory box Sentiero Combo AN1002619. ABR Quick SW AN100337-Quick10. TEOAE Quick SW AN100109-Quick11. Mira PC Patient Management SW AN10011612. Label Printer SW AN10041413. Power Supply Sentiero Advanced US AN101016+AN100993-USA
Catalog Number
-
Brand Name
Sentiero Advanced
Version/Model Number
100340-SC-AT
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EWO
Product Code Name
Audiometer
Public Device Record Key
3eadbced-26f3-4a7c-9fc2-81fa3f4c25e6
Public Version Date
June 30, 2022
Public Version Number
2
DI Record Publish Date
June 27, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 18 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 152 |