Catalog Number

-

Brand Name

ShadowForm Marker

Version/Model Number

VIP1735

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

K964972

Product Code

KPQ

Product Code Name

System, Simulation, Radiation Therapy

Public Device Record Key

5d134497-2928-4670-b17f-3bf8ccbe9b99

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 17, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-