Catalog Number

990044

Brand Name

Mastercast™ Pro

Version/Model Number

990044

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K060737,K093738,K060737,K093738

Product Code

IYE

Product Code Name

Accelerator, linear, medical

Public Device Record Key

60d3dc64-3fb2-4fa8-8853-806f896e7987

Public Version Date

August 03, 2020

Public Version Number

7

DI Record Publish Date

September 25, 2017

Package DI Number

00841439110164

Quantity per Package

10

Contains DI Package

10841439110161

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-