Catalog Number

C-000.17.204

Brand Name

ASPHERIC OPHTHALMIC LENS

Version/Model Number

C-000.17.204

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 21, 2020

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

HJL

Product Code Name

Lens, condensing, diagnostic

Public Device Record Key

5b77ddfd-24f5-43c9-94b9-0c5ac80b8713

Public Version Date

June 17, 2022

Public Version Number

3

DI Record Publish Date

September 17, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-