Catalog Number

-

Brand Name

CT-Markers

Version/Model Number

110614P01

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

33ad6601-f198-4c74-ba5c-d9d2a5715a86

Public Version Date

February 07, 2019

Public Version Number

4

DI Record Publish Date

October 11, 2016

Package DI Number

08717213039049

Quantity per Package

1

Contains DI Package

08717213051072

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-