Catalog Number

-

Brand Name

Varian Mold Frame Kit

Version/Model Number

110470606

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K171733,K181404

Product Code

IYE

Product Code Name

Accelerator, linear, medical

Public Device Record Key

875a5e69-a25a-4ac6-935a-64da1eac4776

Public Version Date

June 07, 2021

Public Version Number

1

DI Record Publish Date

May 29, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-