Catalog Number

1212

Brand Name

3DVH

Version/Model Number

1212

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K131862

Product Code

IYE

Product Code Name

Accelerator, Linear, Medical

Public Device Record Key

63f7f2a8-88e1-45ce-a0cf-87fd656d3fc2

Public Version Date

October 17, 2019

Public Version Number

1

DI Record Publish Date

October 09, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-