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

Duns Number:020198912

Device Description: Tourniquet Color Cuff Dual Port, Double Bladder (Red), Quick Connect

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More Product Details

Catalog Number

5921-018-245

Brand Name

N/A

Version/Model Number

N/A

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

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

81c88b2d-d09a-4174-8570-a416234132e7

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

50885825016413

Quantity per Package

10

Contains DI Package

00885825016418

Package Discontinue Date

-

Package Status

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