Sentiero Desktop AuDX PRO FLEX - Sentiero Desktop AuDX PRO FLEX - PATH medical GmbH

Duns Number:551540334

Device Description: Sentiero Desktop AuDX PRO FLEX Set:Content:1. Sentiero Desktop AN100434-AUPF2. Cardboard B Sentiero Desktop AuDX PRO FLEX Set:Content:1. Sentiero Desktop AN100434-AUPF2. Cardboard Box AN1007283. Cardboard Sleeve Bio-Logic AN100723-Biologic4. Probe EP-TY long AN100188-US5. Accessory box Combo AB-03 AN100261-BL6. Accessory box AB08 AN100734-P7. FW Screening Tymp class 2 AN1005608. Software label printer AN1004149. USB data cable AN10041810. USB stick Bio-Logic AN100724-BL11. Test cavity tymp AN10054912. Power supply Sentiero Desktop FW7662M AN100524 or FW8002.1M AN101360 optionally13. Power supply adapter Sentiero Desktop US AN100525-USA or AN101251-USA optionally14. Manual Bio-Logic AN100904-EN-BL

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More Product Details

Catalog Number

100497-BL-US1

Brand Name

Sentiero Desktop AuDX PRO FLEX

Version/Model Number

8-04-16540

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

ETY

Product Code Name

Tester, Auditory Impedance

Device Record Status

Public Device Record Key

24f73d05-0923-47d0-a743-0ee36ffcddaa

Public Version Date

September 29, 2022

Public Version Number

4

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