Catalog Number

-

Brand Name

uDR

Version/Model Number

uDR 596i

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K181413,K192293

Product Code

KPR

Product Code Name

System, X-Ray, Stationary

Public Device Record Key

bae5c084-77ef-4009-9f82-70b4bd48f4d0

Public Version Date

April 24, 2020

Public Version Number

2

DI Record Publish Date

December 28, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-