Duns Number:551540334
Device Description: Sentiero AuDX SetContent:1. Sentiero Screening device AN100098-AU2. Carrying case AN100928 Sentiero AuDX SetContent:1. Sentiero Screening device AN100098-AU2. Carrying case AN1009283. Inlay AN1006774. Probe EP-DP Path long AN100028-US5. Accessory box Combo AB-03 AN100261-BL6. DPOAE Quick Software AN100110-Quick7. FMDPOAE Software AN1005368. Software label printer AN1004149. USB data cable AN10008910. USB stick Bio-Logic AN100724-BL11. Power supply Sentiero AN101013+AN100993-USA12. Manual Bio-Logic AN100904-EN-BL
Catalog Number
100250-BL-US2
Brand Name
Sentiero AuDX
Version/Model Number
8-04-16510
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
K133012
Product Code
EWO
Product Code Name
Audiometer
Public Device Record Key
73bca970-907f-4a7b-b994-8899112b12cb
Public Version Date
June 24, 2020
Public Version Number
5
DI Record Publish Date
June 01, 2018
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 |