DRX - Ascend System - QG-TV-CM - CARESTREAM HEALTH, INC.

Duns Number:793169512

Device Description: QG-TV-CM

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

6574644

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

Product Characteristics

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 Details

Product Code

LMD

Product Code Name

System, digital image communications, radiological

Device Record Status

Public Device Record Key

443323a4-40c5-4954-b213-d5049f0ed634

Public Version Date

May 25, 2020

Public Version Number

1

DI Record Publish Date

May 15, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CARESTREAM HEALTH, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 328
2 A medical device with a moderate to high risk that requires special controls. 688