Catalog Number

-

Brand Name

TruCompress

Version/Model Number

SUP1086WBXL

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

ITW

Product Code Name

Joint, Ankle, External Brace

Public Device Record Key

7ca8e643-f3cd-4083-8607-e12451217941

Public Version Date

July 07, 2020

Public Version Number

3

DI Record Publish Date

March 24, 2019

Package DI Number

10818323023494

Quantity per Package

60

Contains DI Package

00818323023497

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case