Catalog Number

8010142-01

Brand Name

VERITON CT

Version/Model Number

VERITON CT 64

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

K182484

Product Code

JAK

Product Code Name

System, X-Ray, Tomography, Computed

Public Device Record Key

c7523863-99f5-4d61-ad2a-05c3cd05ef8f

Public Version Date

January 11, 2019

Public Version Number

1

DI Record Publish Date

December 11, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-