Catalog Number

-

Brand Name

DuraDiagnost

Version/Model Number

712203

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"

Yes

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

K201640

Product Code

KPR

Product Code Name

System, x-ray, stationary

Public Device Record Key

0597d8d6-7af7-484e-875d-034c4e64d481

Public Version Date

September 14, 2020

Public Version Number

1

DI Record Publish Date

September 04, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-