Catalog Number

MTM410

Brand Name

C-Qual M™

Version/Model Number

MTM410

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 30, 2022

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K211001

Product Code

IYE

Product Code Name

Accelerator, linear, medical

Public Device Record Key

0f3b7969-d6e4-4277-a562-82db6cbee221

Public Version Date

August 01, 2022

Public Version Number

3

DI Record Publish Date

August 14, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-