Catalog Number

-

Brand Name

UCAST

Version/Model Number

U-ANKLE

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)

-

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

6651d127-4118-40a6-8530-f98b80e84314

Public Version Date

October 10, 2022

Public Version Number

1

DI Record Publish Date

September 30, 2022

Package DI Number

06450053264319

Quantity per Package

10

Contains DI Package

06430053264113

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pouch