Catalog Number

ea

Brand Name

Stryker Tourniquet

Version/Model Number

RM-5921-218-235

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KCY

Product Code Name

Tourniquet, Pneumatic

Public Device Record Key

ec091a6c-c56b-4600-a859-a9b6ab3ab36a

Public Version Date

May 10, 2021

Public Version Number

2

DI Record Publish Date

March 11, 2020

Package DI Number

10816317023789

Quantity per Package

10

Contains DI Package

00816317023782

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case