Sentiero AuDX PRO - Sentiero AuDX PRO Set:Content:1. Sentiero - PATH medical GmbH

Duns Number:551540334

Device Description: Sentiero AuDX PRO Set:Content:1. Sentiero Diagnostic device AN100098-AUP2. Carrying case A Sentiero AuDX PRO Set:Content:1. Sentiero Diagnostic device AN100098-AUP2. Carrying case AN1009283. Inlay AN1006774. Probe EP-DP Path long AN100028-US5. Accessory box Combo AB-03 AN100261-BL6. TEOAE Software AN1001097. DPOAE Software AN1001108. FMDPOAE Software AN1005369. DPHiRes Software AN10053710. Software label printer AN10041411. PC Patient Management Software AN10011612. USB data cable AN10008913. USB stick Bio-Logic AN100724-BL14. Power supply Sentiero AN101013+AN100993-USA15. Manual Bio-Logic AN100904-EN-BL

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More Product Details

Catalog Number

100250-BL-US4

Brand Name

Sentiero AuDX PRO

Version/Model Number

8-04-16530

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

bea2c0a3-9408-43e9-972b-406f8a9783fc

Public Version Date

June 24, 2020

Public Version Number

3

DI Record Publish Date

June 01, 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