Catalog Number

7210414

Brand Name

Trivex System

Version/Model Number

7210414

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

-

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

K032387

Product Code

DWQ

Product Code Name

Stripper, Vein, External

Public Device Record Key

3318b943-2348-46c6-9b70-83496d5cbca7

Public Version Date

April 21, 2021

Public Version Number

4

DI Record Publish Date

July 15, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-