Catalog Number

8010184-01

Brand Name

VERITON NM

Version/Model Number

001

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

K180514

Product Code

KPS

Product Code Name

System, Tomography, Computed, Emission

Public Device Record Key

f34b1d28-1aff-419c-8178-894310d5a2c2

Public Version Date

December 10, 2018

Public Version Number

1

DI Record Publish Date

November 08, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-