Catalog Number

7800TLC-TN

Brand Name

Coflex TLC

Version/Model Number

Tan, 4"

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"

Yes

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

MHW

Product Code Name

Dressing, Compression

Public Device Record Key

3da25045-04fd-4411-bd86-20ce115fe463

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

March 22, 2022

Package DI Number

00724004610675

Quantity per Package

8

Contains DI Package

10724004610672

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case