Catalog Number

-

Brand Name

SynergEyes casted button

Version/Model Number

petrafocon A hem-larafilcon A

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

MR Safe

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K083921

Product Code

HQD

Product Code Name

Lens, Contact (Other Material) - Daily

Public Device Record Key

292717be-6b36-4546-a254-1b3f9ecc0214

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 14, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-