Catalog Number

66020016

Brand Name

PROFORE KIT USA ANKLE 18-25CM

Version/Model Number

66020016

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FQM

Product Code Name

Bandage, Elastic

Public Device Record Key

e77e1c80-b14a-4933-8309-4cbaeac765a2

Public Version Date

June 22, 2021

Public Version Number

2

DI Record Publish Date

April 09, 2020

Package DI Number

05000223481926

Quantity per Package

8

Contains DI Package

05000223411244

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case