Catalog Number

RV02

Brand Name

RELIEVA VORTEX 2

Version/Model Number

RV02

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KAR

Product Code Name

IRRIGATOR, SINUS

Public Device Record Key

c55e7b4a-8705-4b8a-a9eb-1889ab955862

Public Version Date

January 22, 2020

Public Version Number

4

DI Record Publish Date

October 01, 2016

Package DI Number

20705031205878

Quantity per Package

5

Contains DI Package

10705031205871

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX