Catalog Number

-

Brand Name

Iris

Version/Model Number

Iris CK 3Tone/TURQUOISE

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

LPL

Product Code Name

Lenses, Soft Contact, Daily Wear

Public Device Record Key

64a694b7-5e74-4d34-bb2d-f9fcf8ef4ffa

Public Version Date

November 08, 2021

Public Version Number

3

DI Record Publish Date

September 07, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-