Catalog Number

94039HZ

Brand Name

REVITALENS

Version/Model Number

94039HZ

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

LPN

Product Code Name

Accessories, soft lens products

Public Device Record Key

e404e286-eec1-44ba-8f1c-b0a96493b757

Public Version Date

February 26, 2020

Public Version Number

4

DI Record Publish Date

September 09, 2016

Package DI Number

30827444001209

Quantity per Package

4

Contains DI Package

20827444001202

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case