Catalog Number

-

Brand Name

Riptide™

Version/Model Number

MAC-1200

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"

-

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

K172448

Product Code

NRY

Product Code Name

CATHETER, THROMBUS RETRIEVER

Public Device Record Key

4a7d07b2-176e-4258-b909-076b6c9ad960

Public Version Date

January 08, 2021

Public Version Number

2

DI Record Publish Date

August 24, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-