Catalog Number

8604217

Brand Name

DRX - Ascend System

Version/Model Number

DRX - Ascend System

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

K011486

Product Code

KPR

Product Code Name

System, x-ray, stationary

Public Device Record Key

b24b72d5-c5bf-428f-8930-398c67260d3d

Public Version Date

January 15, 2019

Public Version Number

4

DI Record Publish Date

January 21, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-