Catalog Number

11780000Z

Brand Name

MapCHECK 3

Version/Model Number

11780000Z

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 15, 2019

Issuing Agency

In HIBCC

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

K131466

Product Code

IYE

Product Code Name

Accelerator, Linear, Medical

Public Device Record Key

d7f81c36-d55c-4e8f-823a-dbba881715c4

Public Version Date

April 16, 2019

Public Version Number

4

DI Record Publish Date

November 07, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-