Catalog Number

8604118

Brand Name

DRX - Ascend System

Version/Model Number

DRX - Ascend System

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 18, 2019

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

db44a115-7037-4413-a756-135f515634cf

Public Version Date

January 24, 2019

Public Version Number

6

DI Record Publish Date

January 27, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-