Catalog Number

R51411-00-00

Brand Name

Rocket

Version/Model Number

R51411-00-00

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

-

Product Code

DWM

Product Code Name

APPARATUS, SUCTION, PATIENT CARE

Public Device Record Key

6bef1475-7fe8-4198-bf4e-7632b69292e4

Public Version Date

June 26, 2019

Public Version Number

1

DI Record Publish Date

June 18, 2019

Package DI Number

05055270971623

Quantity per Package

5

Contains DI Package

05055270971609

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box