Catalog Number

-

Brand Name

Disposable Direct Image Flat SSV (VFLATSSVD)

Version/Model Number

VFLATSSVD

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

b16412e4-f002-4b93-b53e-94ea72276b8d

Public Version Date

September 30, 2020

Public Version Number

4

DI Record Publish Date

September 29, 2016

Package DI Number

30811608013269

Quantity per Package

800

Contains DI Package

00811608013268

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE