Catalog Number

-

Brand Name

Keenhealth

Version/Model Number

K-PC-195-L

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

MRI

Product Code Name

Orthosis, Truncal/Orthosis, Limb

Public Device Record Key

f03204bc-7ab4-4c15-b35e-fe5ac634f5c4

Public Version Date

October 30, 2019

Public Version Number

2

DI Record Publish Date

September 20, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-