Catalog Number

-

Brand Name

Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens

Version/Model Number

CC4204A

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

P990013

Product Code

HQL

Product Code Name

Intraocular Lens

Public Device Record Key

3e5807ea-e8fb-4ca8-8d96-7e812d1f0224

Public Version Date

July 08, 2021

Public Version Number

4

DI Record Publish Date

October 20, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-