Catalog Number

-

Brand Name

SIUI

Version/Model Number

SR-8210S

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

K200976

Product Code

IZL

Product Code Name

System, X-Ray, Mobile

Public Device Record Key

7e40d8cb-c4fb-40fa-8a8d-810f5daa5b58

Public Version Date

September 11, 2020

Public Version Number

1

DI Record Publish Date

September 03, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-