Catalog Number

94136

Brand Name

REVITALENS

Version/Model Number

94136

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

aa2e7747-a7df-4054-8aff-6a21b33bea84

Public Version Date

February 26, 2020

Public Version Number

4

DI Record Publish Date

September 09, 2016

Package DI Number

30827444001377

Quantity per Package

12

Contains DI Package

00827444001376

Package Discontinue Date

November 08, 2017

Package Status

Not in Commercial Distribution

Package Type

Case