Catalog Number

990045

Brand Name

Mastercast™ Pro

Version/Model Number

990045

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 30, 2022

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

566b62f8-dedd-436a-86ee-c39537c0685a

Public Version Date

August 01, 2022

Public Version Number

9

DI Record Publish Date

September 25, 2017

Package DI Number

00841439110171

Quantity per Package

10

Contains DI Package

10841439110178

Package Discontinue Date

July 30, 2022

Package Status

Not in Commercial Distribution

Package Type

-