Catalog Number

-

Brand Name

CT-Markers

Version/Model Number

110615P01-01

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

-

Product Code

JAC

Product Code Name

System, x-ray, film marking, radiographic

Public Device Record Key

3905a41d-fd8d-499f-b8f1-1b67e78a580e

Public Version Date

February 07, 2019

Public Version Number

4

DI Record Publish Date

May 25, 2017

Package DI Number

08717213039056

Quantity per Package

1

Contains DI Package

08717213051089

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-