Catalog Number

1179000-0Z

Brand Name

SRS MapCHECK

Version/Model Number

1179300Z

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

ec1b0272-b579-49fa-abcd-cda48e803036

Public Version Date

July 30, 2020

Public Version Number

1

DI Record Publish Date

July 22, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-