Catalog Number

-

Brand Name

Multi-Modality Markers

Version/Model Number

MM3005CLM

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K014022

Product Code

IYE

Product Code Name

Accelerator, Linear, Medical

Public Device Record Key

4a624922-519b-4be9-9c32-7e61de11853c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 26, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-