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

Duns Number:196548481

Device Description: Non-Sterile Reusable Tourniquet Cuff Single Bladder, Dual Port and Quick Connect Connector

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More Product Details

Catalog Number

5922-015-235

Brand Name

Color Cuff

Version/Model Number

5922015235

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

687c66bf-ab96-4c81-8537-a008a2a7fa2c

Public Version Date

September 24, 2020

Public Version Number

2

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