QW-420 - QUANTUM 43 IN X 43 IN FIXED NO-TILT WS - CARESTREAM HEALTH, INC.

Duns Number:793169512

Device Description: QUANTUM 43 IN X 43 IN FIXED NO-TILT WS

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More Product Details

Catalog Number

AA3396

Brand Name

QW-420

Version/Model Number

QW-420

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

IXY

Product Code Name

Holder, radiographic cassette, wall-mounted

Device Record Status

Public Device Record Key

042688cd-4450-4435-9709-04e28144c893

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 23, 2016

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