Catalog Number

R57591-ET-23

Brand Name

Rocket

Version/Model Number

R57591-ET-23

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

K994327,K994327,K994327

Product Code

-

Product Code Name

-

Public Device Record Key

796a461c-a011-4918-b48d-2dbc0c91ec07

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 09, 2016

Package DI Number

05055270967213

Quantity per Package

8

Contains DI Package

05055270967206

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-