Duns Number:551540334
Device Description: Sentiero Desktop Screening Set US1Sentiero Desktop Screening Set Tymp with IPSI ReflexCont Sentiero Desktop Screening Set US1Sentiero Desktop Screening Set Tymp with IPSI ReflexContent:1. Sentiero Desktop (Tymp Screening) AN100434-SB2. USB data cable AN1004183. Probe EP-TY long AN100188-US4. FW Screening Tymp class 2 AN1005605. Software label printer AN1004146. Accessory box for Tymp probe AN1005877. Accessory box AB08 AN100734-P8. Power supply Senti / Sentiero Desktop FW7662M AN100524 or FW8002.1M AN101360 optionally9. Power supply adapter Senti / Sentiero Desktop USA/-UK/-EU/-AUS AN100525-USA/-UK/-EU/-AUS or AN101251-USA/-UK/-EU/-AUS optionally10. Test cavity tymp AN100549
Catalog Number
-
Brand Name
Sentiero Desktop Screening
Version/Model Number
100497-US1
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
ETY
Product Code Name
Tester, Auditory Impedance
Public Device Record Key
332c20c5-651a-49fb-a962-5a466e2879f1
Public Version Date
September 29, 2022
Public Version Number
5
DI Record Publish Date
August 31, 2016
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 |