Green X-ray Film WB - 25SH 14X36IN (FLAT) GREEN X-RAY WB - CARESTREAM HEALTH, INC.

Duns Number:793169512

Device Description: 25SH 14X36IN (FLAT) GREEN X-RAY WB

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


More Product Details

Catalog Number

6041370

Brand Name

Green X-ray Film WB

Version/Model Number

Green X-ray Film WB

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 11, 2017

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

Yes

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

IWZ

Product Code Name

Film, radiographic

Device Record Status

Public Device Record Key

726ca7fe-b2f1-476e-9602-82a0c7f29975

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 16, 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