Catalog Number

MKN35085

Brand Name

T.E.D.

Version/Model Number

MKN35085

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)

Yes

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

bf44ff07-299c-4447-bc33-5a1fc6bba59b

Public Version Date

July 07, 2020

Public Version Number

7

DI Record Publish Date

September 24, 2016

Package DI Number

20884521167220

Quantity per Package

12

Contains DI Package

00884521167226

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE