Catalog Number

11790000Z

Brand Name

SRS MapCHECK

Version/Model Number

11790000Z

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

MR Unsafe

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

3b0fa1d4-625c-4edf-bc04-5c08b1bfaee8

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

May 31, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-