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

Duns Number:793169512

Device Description: 125SH 35X43CM (14X17IN) DVB+ CE

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More Product Details

Catalog Number

1069590

Brand Name

DRYVIEW DVB+ Laser Imaging Film

Version/Model Number

DRYVIEW DVB+ Laser Imaging Film

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

3147d3a1-83e0-4dea-b598-c4572e1a9279

Public Version Date

September 01, 2022

Public Version Number

3

DI Record Publish Date

December 22, 2017

Additional Identifiers

Package DI Number

60889971069597

Quantity per Package

4

Contains DI Package

40889971069593

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