Catalog Number

1614

Brand Name

Knee Support Orthopedic Knee Brace

Version/Model Number

83101-83106

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

IQI

Product Code Name

Orthosis, Limb Brace

Public Device Record Key

f5298ff0-88e9-454c-9522-cd961a3b7f92

Public Version Date

October 03, 2022

Public Version Number

4

DI Record Publish Date

August 07, 2018

Package DI Number

10891237001611

Quantity per Package

48

Contains DI Package

00891237001614

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer Case