Catalog Number

6701536

Brand Name

Value Systems

Version/Model Number

Value Systems

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K201373

Product Code

KPR

Product Code Name

System, x-ray, stationary

Public Device Record Key

a3446b08-1e38-48ca-b9fc-7159a503aa0a

Public Version Date

October 05, 2020

Public Version Number

1

DI Record Publish Date

September 26, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-