Catalog Number

R54544-GW

Brand Name

Rocket

Version/Model Number

R54544-GW

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"

Yes

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

-

Product Code Name

-

Public Device Record Key

1b8fed5c-c7a4-4a40-8444-4fcab5498140

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

January 09, 2017

Package DI Number

05055270966674

Quantity per Package

30

Contains DI Package

05055270966667

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box