Sentiero Basic AuDX PRO Set - Basic Set for AuDX PRO branded SentieroContent:- - PATH medical GmbH

Duns Number:551540334

Device Description: Basic Set for AuDX PRO branded SentieroContent:- carrying bag A/N100503- USB cable A/N1000 Basic Set for AuDX PRO branded SentieroContent:- carrying bag A/N100503- USB cable A/N100089- AuDX PRO A/N100098-AUP- Headphone HDA300 A/N100630- Probe EP-DP PATH long A/N100028-US- Gooseneck microphone A/N 100779- FW TEOAE A/N100109- FW DPOAE A/N100110- FW FMDPOAE A/N100536- FW DPHiRES A/N 100537- FW PTA Class 3 A/N100114- FW High frequency A/N100454- FW Magic A/N100112- Speech material Spondees child A/N100463-UT08- Speech material Spondees adult A/N100463-UT10- Speech material NU-6 A/N100463-UT11- Speech material CID W-22 A/N100463-UT12- Speech material PBK-50 A/N100463-UT13- Speech material Maryland CNC A/N100463-UT15- FW Live A/N100825- FW Mira PC- Software A/N100116- FW Labelprinter A/N100414- Accessory box combo A/N100261- Power Supply Sentiero US A/N100083-US- User Manual A/N100904-EN-BL

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More Product Details

Catalog Number

-

Brand Name

Sentiero Basic AuDX PRO Set

Version/Model Number

100250-BLP1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 29, 2020

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

d3a0750d-633e-4fff-980c-9c4009889df8

Public Version Date

June 30, 2020

Public Version Number

3

DI Record Publish Date

April 10, 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