Catalog Number

-

Brand Name

Right Way Medical

Version/Model Number

RWM-IFRF01

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K111351,K111351,K111351

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

9d810cbb-fd5d-4533-b145-a48179d52615

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

March 01, 2021

Package DI Number

00860006128029

Quantity per Package

40

Contains DI Package

00860006128012

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box