Catalog Number

R51400-16-PL

Brand Name

Rocket

Version/Model Number

R51400-16-PL

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

K123033,K123033

Product Code

-

Product Code Name

-

Public Device Record Key

979307d9-6f1e-48f2-a809-4ff948c1956f

Public Version Date

September 09, 2020

Public Version Number

4

DI Record Publish Date

September 20, 2016

Package DI Number

05055270965745

Quantity per Package

5

Contains DI Package

05055270965721

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-