Catalog Number

-

Brand Name

Disposable Direct Image WideField (VWFD)

Version/Model Number

VWFD

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

HJK

Product Code Name

Lens, Contact, Polymethylmethacrylate, Diagnostic

Public Device Record Key

bc36f9b9-b547-49e7-a1b4-79905c22d19f

Public Version Date

September 30, 2020

Public Version Number

4

DI Record Publish Date

September 29, 2016

Package DI Number

30811608017243

Quantity per Package

800

Contains DI Package

00811608017242

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE