Catalog Number

-

Brand Name

Single Use 28D

Version/Model Number

V28LCD

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

HJL

Product Code Name

Lens, Condensing, Diagnostic

Public Device Record Key

efae0247-b649-43f1-af7c-8c749faebe0f

Public Version Date

June 17, 2022

Public Version Number

2

DI Record Publish Date

September 24, 2020

Package DI Number

10811608018970

Quantity per Package

10

Contains DI Package

00811608018973

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX