Sentiero Screening2 - Sentiero Screening2 Audio and TEOAE - PATH medical GmbH

Duns Number:551540334

Device Description: Sentiero Screening2 Audio and TEOAE SetContent:1. Case AN1005032. Inlay Sentiero AN1006773 Sentiero Screening2 Audio and TEOAE SetContent:1. Case AN1005032. Inlay Sentiero AN1006773. USB data cable AN1000894. Sentiero Screening2 device with touchscreen AN100098-S25. Headphone DD-45 AN1003066. Probe EP-DP Path long AN100028-US7. Audio Class4 Advanced Software AN1006538. TEOAE Quick Software AN100109-Quick9. Software label printer AN10041410. Accessory box Sentiero PT-S AN10090211. Power supply Sentiero US AN101013+AN100993-USA

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More Product Details

Catalog Number

-

Brand Name

Sentiero Screening2

Version/Model Number

100250-SC-AuT

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

K133012

Product Code Details

Product Code

EWO

Product Code Name

Audiometer

Device Record Status

Public Device Record Key

f22eb8e1-3a6d-42d6-91a9-7ccfc063f1e1

Public Version Date

July 06, 2020

Public Version Number

1

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