ZonedIn Vision Contact Lenses - Daily wear soft contact lens +1.50 power 2 trials - ZONEDIN VISION, LLC

Duns Number:117142079

Device Description: Daily wear soft contact lens +1.50 power 2 trials

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More Product Details

Catalog Number

058

Brand Name

ZonedIn Vision Contact Lenses

Version/Model Number

058

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K083288

Product Code Details

Product Code

LPL

Product Code Name

Lenses, soft contact, daily wear

Device Record Status

Public Device Record Key

9bf0bc8c-cdfe-4e88-94f0-5c12fbeafc17

Public Version Date

February 01, 2021

Public Version Number

1

DI Record Publish Date

January 22, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ZONEDIN VISION, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 415