Catalog Number

1253988

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

October 31, 2016

Issuing Agency

In GS1

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

IWZ

Product Code Name

Film, radiographic

Public Device Record Key

c703d953-f8bf-40dc-ab25-27e67a2fd98f

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 16, 2016

Package DI Number

60889971253989

Quantity per Package

4

Contains DI Package

40889971253985

Package Discontinue Date

October 31, 2016

Package Status

Not in Commercial Distribution

Package Type

Case