Vista Plus - Vista Plus 30PK3.75 - Optimax Eyewear, Inc.

Duns Number:118283558

Device Description: Vista Plus 30PK3.75

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More Product Details

Catalog Number

-

Brand Name

Vista Plus

Version/Model Number

181-0000025P0375000000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

LPL

Product Code Name

Lenses, Soft Contact, Daily Wear

Device Record Status

Public Device Record Key

3c96637c-fea9-4282-a078-fa24a9902b05

Public Version Date

January 24, 2022

Public Version Number

1

DI Record Publish Date

January 14, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"OPTIMAX EYEWEAR, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 15