Catalog Number

R57424-00-ST

Brand Name

Rocket

Version/Model Number

R57424-00-ST

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K000340,K000340,K000340

Product Code

-

Product Code Name

-

Public Device Record Key

095c2e93-7ee7-485d-b66c-34c78d37a5fc

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 22, 2016

Package DI Number

05055270973528

Quantity per Package

10

Contains DI Package

05055270973511

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-