Sentiero Advanced - Sentiero Advanced ABR, OAE, Tympanometry and - PATH medical GmbH

Duns Number:551540334

Device Description: Sentiero Advanced ABR, OAE, Tympanometry and Audio Screening SetContent:1. Case AN1005032. Sentiero Advanced ABR, OAE, Tympanometry and Audio 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. Headphone DD-45 AN1003068. Probe EP-DP Path long AN100028-US9. Accessory box Sentiero Combo AN10026110. ABR Quick SW AN100337-Quick11. TEOAE Quick SW AN100109-Quick12. DPOAE Quick SW AN100110-Quick13. FMDPOAE SW AN10053614. Tymp Class 2 SW AN10056015. Audio Class 4 Advanced SW AN10065316. Mira PC Patient Management SW AN10011617. Label Printer SW AN10041418. Power Supply Sentiero Advanced US AN101016+AN100993-USA19. Tympanometry add-on TY-MA AN10094720. Accessory box AB08 AN100734-P21. Tympanometry cavity AN10054922. Probe tip small PT-S AN100014-W (3 pcs.)23. Probe tip medium PT-A AN100013 (5 pcs.)

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Sentiero Advanced

Version/Model Number

100340-SC-ALL

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

ETY

Product Code Name

Tester, Auditory Impedance

Device Record Status

Public Device Record Key

6a03b03c-3c44-4653-a218-30155c55c83e

Public Version Date

June 30, 2022

Public Version Number

3

DI Record Publish Date

June 27, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PATH MEDICAL GMBH" Characteristics
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