Catalog Number

3000399

Brand Name

NA

Version/Model Number

3000399

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 15, 2022

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

OWB

Product Code Name

Interventional fluoroscopic x-ray system

Public Device Record Key

eeb2f0b6-8dac-406b-a89e-7335b81d3716

Public Version Date

June 21, 2022

Public Version Number

3

DI Record Publish Date

July 21, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-