Catalog Number

-

Brand Name

PolyVue

Version/Model Number

Clalen / -04.00

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

325b3d73-286f-425c-9f73-b792afefb97f

Public Version Date

August 18, 2022

Public Version Number

1

DI Record Publish Date

August 10, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-