N/A - Tourniquet Color Cuff Single Port, Single Bladder - STRYKER SUSTAINABILITY SOLUTIONS, INC.

Duns Number:020198912

Device Description: Tourniquet Color Cuff Single Port, Single Bladder (Light Blue), Quick Connect

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More Product Details

Catalog Number

5921-209-135

Brand Name

N/A

Version/Model Number

N/A

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 06, 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

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 Details

Product Code

KCY

Product Code Name

TOURNIQUET, PNEUMATIC

Device Record Status

Public Device Record Key

ffa155ba-f56f-439a-86a5-9ee13a0c0f9b

Public Version Date

February 08, 2021

Public Version Number

4

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

50885825016475

Quantity per Package

10

Contains DI Package

00885825016470

Package Discontinue Date

February 06, 2021

Package Status

Not in Commercial Distribution

Package Type

case

"STRYKER SUSTAINABILITY SOLUTIONS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 304
2 A medical device with a moderate to high risk that requires special controls. 1702
U Unclassified 12