Catalog Number

D128624

Brand Name

Carto 3

Version/Model Number

D128624

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

K090017

Product Code

DQK

Product Code Name

COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Public Device Record Key

9b3870d6-433f-4be6-990d-9c82111e1ca9

Public Version Date

February 10, 2022

Public Version Number

5

DI Record Publish Date

September 16, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-