Catalog Number

1107081-01

Brand Name

Varian RPM Gating Marker Block (2 Dot)

Version/Model Number

1107081-01

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K102024,K102024

Product Code

IYE

Product Code Name

Accelerator, linear, medical

Public Device Record Key

181cc82b-755e-4b9b-95a7-338ebace28db

Public Version Date

March 16, 2021

Public Version Number

1

DI Record Publish Date

March 08, 2021

Package DI Number

10858086006389

Quantity per Package

5

Contains DI Package

00858086006382

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

5-Pack