Catalog Number

9806-058-01201

Brand Name

CT8000

Version/Model Number

9806-058-01201

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

ITY

Product Code Name

Assembly, tube housing, x-ray, diagnostic

Public Device Record Key

33beb9b0-c862-46c8-93e7-ac7664125da0

Public Version Date

November 20, 2019

Public Version Number

1

DI Record Publish Date

November 12, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-