Sentiero Advanced - Sentiero Advanced ABR US0Content:1. Case - PATH medical GmbH

Duns Number:551540334

Device Description: Sentiero Advanced ABR US0Content:1. Case AN1005032. Inlay Sentiero AN1006773. USB data cab Sentiero Advanced ABR US0Content: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. PATH Insert Earphones (PIEP) AN1008608. ABR Quick SW AN100337-Quick8. Binaural ABR SW AN1004249. Label Printer SW AN10041410. Power Supply Sentiero Advanced AN101016 + AN100993-USA

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More Product Details

Catalog Number

-

Brand Name

Sentiero Advanced

Version/Model Number

100340-US0

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

EWO

Product Code Name

Audiometer

Device Record Status

Public Device Record Key

4af12c75-0ec5-4274-861f-6a9990575588

Public Version Date

June 30, 2022

Public Version Number

5

DI Record Publish Date

October 04, 2018

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