Qualis - HDK Daily Contact Lens_30pk - Unicon Optical Co., Ltd.

Duns Number:657659793

Device Description: HDK Daily Contact Lens_30pk

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More Product Details

Catalog Number

-

Brand Name

Qualis

Version/Model Number

+4.00

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

d5dea882-d546-47d1-add8-26afd47c8f6f

Public Version Date

July 11, 2022

Public Version Number

1

DI Record Publish Date

July 01, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"UNICON OPTICAL CO., LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 59