Catalog Number

-

Brand Name

VERSA HD Disposable LenZ

Version/Model Number

54216

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

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

b09b2a78-280a-4aad-b573-00254b76fc11

Public Version Date

June 17, 2022

Public Version Number

3

DI Record Publish Date

December 04, 2020

Package DI Number

00852475007271

Quantity per Package

12

Contains DI Package

00852475007264

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case