Catalog Number

-

Brand Name

superDimension

Version/Model Number

SDC10

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 06, 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"

Yes

For Single-Use

Yes

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

-

Product Code

IYE

Product Code Name

Accelerator, linear, medical

Public Device Record Key

8a7d634d-3f2a-4c77-9883-bea33b8b941d

Public Version Date

June 10, 2022

Public Version Number

8

DI Record Publish Date

September 24, 2016

Package DI Number

20884521197708

Quantity per Package

5

Contains DI Package

10884521197701

Package Discontinue Date

April 06, 2018

Package Status

Not in Commercial Distribution

Package Type

CASE