Catalog Number

-

Brand Name

SIUI

Version/Model Number

SR-1000

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

Yes

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

-

FDA Premarket Submission

K202350

Product Code

IZL

Product Code Name

System, X-Ray, Mobile

Public Device Record Key

e09295b8-7d58-4bb4-b95b-efeb54f94522

Public Version Date

January 20, 2021

Public Version Number

1

DI Record Publish Date

January 12, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-