Catalog Number

1102631

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

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

df8066d8-2189-4666-b1dc-298adfe3fce5

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 16, 2016

Package DI Number

60889971102638

Quantity per Package

4

Contains DI Package

40889971102634

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case