Catalog Number

R51401-16-PT

Brand Name

Rocket

Version/Model Number

R51401-16-PT

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

K152105,K152105

Product Code

-

Product Code Name

-

Public Device Record Key

392bc54a-bf1c-46fb-a92c-3080cd97b405

Public Version Date

September 09, 2020

Public Version Number

4

DI Record Publish Date

September 22, 2016

Package DI Number

05055270972491

Quantity per Package

5

Contains DI Package

05055270972477

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-