Catalog Number

-

Brand Name

Elastic UV-Absorbing Silicone Posterior Chamber Intraocular Lens-Toric Optic

Version/Model Number

AA4203TL

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

P880091

Product Code

MJP

Product Code Name

Lens, Intraocular, Toric Optics

Public Device Record Key

c82ed99b-073a-4c8f-99e8-0e86aa3331cc

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

-