dorsaVi - Single use disposable application pad adhesive - DORSAVI LTD

Duns Number:757139956

Device Description: Single use disposable application pad adhesive for use with dorsaVi Version 6 Sensors.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

RS-A482

Brand Name

dorsaVi

Version/Model Number

V6 Sensor Adhesive

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

Yes

Prescription Use (Rx)

-

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

HCC

Product Code Name

Device, Biofeedback

Device Record Status

Public Device Record Key

5fa7d6c6-f616-47b7-9099-b3055b61b35d

Public Version Date

August 12, 2020

Public Version Number

1

DI Record Publish Date

August 04, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DORSAVI LTD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 1