HOLLYWOOD PLATINUM - Color lens(P: 0.00), 2 pcs - GEO Medical Co., Ltd.

Duns Number:687453667

Device Description: Color lens(P: 0.00), 2 pcs

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More Product Details

Catalog Number

-

Brand Name

HOLLYWOOD PLATINUM

Version/Model Number

FL-D33 Green

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K110835

Product Code Details

Product Code

LPL

Product Code Name

Lenses, Soft Contact, Daily Wear

Device Record Status

Public Device Record Key

f092dcf5-7a7e-47af-8626-674eaf887b2b

Public Version Date

January 18, 2022

Public Version Number

1

DI Record Publish Date

January 10, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GEO MEDICAL 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. 4