Green X-ray Film WB - 100SH 35X35-14X14 GREEN X-RAY WB 8389 - CARESTREAM HEALTH, INC.

Duns Number:793169512

Device Description: 100SH 35X35-14X14 GREEN X-RAY WB 8389

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More Product Details

Catalog Number

1096213

Brand Name

Green X-ray Film WB

Version/Model Number

Green X-ray Film WB

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

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

f31332fe-b2a5-46d6-ba7c-cae599c8bb98

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

60889971096210

Quantity per Package

5

Contains DI Package

40889971096216

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"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