Catalog Number

SDX0350V3.0

Brand Name

SDX System

Version/Model Number

3.0

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2018

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

K121845

Product Code

IYE

Product Code Name

Accelerator, Linear, Medical

Public Device Record Key

98412bb5-d9e8-43a9-9d67-8f78a31b2c4f

Public Version Date

December 31, 2018

Public Version Number

5

DI Record Publish Date

July 25, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-