DRYVIEW DVC Laser Imaging Film - 125SH 35X43CM (14X17IN) DVC CE SBOX - CARESTREAM HEALTH, INC.

Duns Number:793169512

Device Description: 125SH 35X43CM (14X17IN) DVC CE SBOX

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More Product Details

Catalog Number

8795247

Brand Name

DRYVIEW DVC Laser Imaging Film

Version/Model Number

DRYVIEW DVC Laser Imaging Film

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 26, 2018

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

3f24f315-2c46-478a-885a-526e299e1592

Public Version Date

July 30, 2018

Public Version Number

3

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