Catalog Number

TK2

Brand Name

Edwards Lifesciences Vascular Torniquet Kit

Version/Model Number

TK2

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K910221,K910221,K910221

Product Code

DXC

Product Code Name

CLAMP, VASCULAR

Public Device Record Key

5465ea36-692c-482f-94d8-d1e43c214a87

Public Version Date

April 08, 2022

Public Version Number

4

DI Record Publish Date

August 31, 2016

Package DI Number

50690103041793

Quantity per Package

10

Contains DI Package

00690103041798

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper