Catalog Number

12200000MR

Brand Name

ArcCHECK-MR

Version/Model Number

12200000MR

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 18, 2019

Issuing Agency

In HIBCC

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

K160057

Product Code

IYE

Product Code Name

Accelerator, Linear, Medical

Public Device Record Key

5e33dad6-08f1-4c19-9a7e-839506f38291

Public Version Date

June 18, 2019

Public Version Number

5

DI Record Publish Date

January 14, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-