Catalog Number

-

Brand Name

Codonics DirectVista Thermal Film, 810-DVB

Version/Model Number

810-DVB

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

146685c4-1bc0-4374-83cf-08f92bdc6561

Public Version Date

May 25, 2021

Public Version Number

1

DI Record Publish Date

May 17, 2021

Package DI Number

10814905021049

Quantity per Package

5

Contains DI Package

00814905021042

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE