Color Cuff - Non-Sterile Reusable Tourniquet Cuff Single - STRYKER CORPORATION

Duns Number:196548481

Device Description: Non-Sterile Reusable Tourniquet Cuff Single Bladder, Single Port and Luer Lock Connector

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More Product Details

Catalog Number

5922-034-136

Brand Name

Color Cuff

Version/Model Number

5922034136

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2021

Issuing Agency

In GS1

Product Characteristics

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

-

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 Details

Product Code

KCY

Product Code Name

TOURNIQUET, PNEUMATIC

Device Record Status

Public Device Record Key

920aa9a5-59f3-410f-abac-5f379569cad0

Public Version Date

December 31, 2021

Public Version Number

4

DI Record Publish Date

September 24, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STRYKER CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2188
2 A medical device with a moderate to high risk that requires special controls. 3183
U Unclassified 60