Catalog Number

MKN34909

Brand Name

T.E.D.

Version/Model Number

MKN34909

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

DWL

Product Code Name

Stocking, medical support (to prevent pooling of blood in legs)

Public Device Record Key

ae41df53-1c5f-4c4f-ba89-0ca891b70122

Public Version Date

July 07, 2020

Public Version Number

7

DI Record Publish Date

September 24, 2016

Package DI Number

20884521166988

Quantity per Package

12

Contains DI Package

00884521166984

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE