Sentiero Advanced NavPRO ONE - Sentiero NavPRO ONE Set:Content:1. Sentiero - PATH medical GmbH

Duns Number:551540334

Device Description: Sentiero NavPRO ONE Set:Content:1. Sentiero Advance device AN100360-NPO2. Carrying case AN Sentiero NavPRO ONE Set:Content:1. Sentiero Advance device AN100360-NPO2. Carrying case AN1009283. Inlay AN1006774. Insert Earphone PIEP Bio-Logic AN100860-BL5. Bone Conductor B81 AN100888 or B71W AN100344 optionally6. Electrode Trunk Cable AN1008817. Electrode Lead Cable AN100891-18. Electrodes AN1004689. ABR Software AN10033710. ABR Binaural Software AN10042411. ABR FFC Software AN10046612. ECochG Software AN10046413. Software label printer AN10041414. PC Patient Management Software AN10011615. USB data cable AN10008916. USB stick Bio-Logic AN100724-BL17. Power supply Sentiero Advanced US AN100268-US18. Manual Bio-Logic AN100904-EN-BL

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More Product Details

Catalog Number

100340-BL-US1

Brand Name

Sentiero Advanced NavPRO ONE

Version/Model Number

8-04-16550

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

c1f130fc-8086-433e-a62a-47e586cb815f

Public Version Date

June 30, 2022

Public Version Number

5

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