Catalog Number

RED72KIT

Brand Name

RED 72

Version/Model Number

RED72KIT-A

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

NRY

Product Code Name

Catheter, Thrombus Retriever

Public Device Record Key

d24018c8-9662-4c36-9c46-cfa4a0a6d5cc

Public Version Date

August 05, 2022

Public Version Number

2

DI Record Publish Date

August 19, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-