Sentiero Advanced NavPRO One Set - content:- carrying bag A/N100503- USB cable - PATH medical GmbH

Duns Number:551540334

Device Description: content:- carrying bag A/N100503- USB cable A/N100089- ABR electrodes A/N100468- NavPRO On content:- carrying bag A/N100503- USB cable A/N100089- ABR electrodes A/N100468- NavPRO One A/N100360-NPO- Electrode trunk cable A/N100881- electrode lead cable A/N100891-1- Heaphone HB7/DD45 A/N100306-US- Probe EP-DP PATH long A/N100028-US- Bone Conductor B71 A/N100344- Gooseneck Microphone A/N100779- FW ABR 100337- FW eABR A/N100929- FW ASSR A/N100465- FW ECochG A/N100464- FW TEOAE A/N100109- FW DPOAE A/N100110- FW FMPDOAE A/N100536- FW DPHiRES A/N100537- FW PTA3 A/N 100114- FW High Frequency A/N100454- FW Magic A/N100112- FW Labelprinter A/N100414- FW Mira PC- Software A/N100116- Accessory Box Combo A/N100261- Power Supply US Sentiero Advanced A/N100268-US- User Manual A/N100904-EN-BL

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More Product Details

Catalog Number

-

Brand Name

Sentiero Advanced NavPRO One Set

Version/Model Number

100340-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

453b89cc-590f-48f2-8215-fd8163654e5f

Public Version Date

June 30, 2022

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