Vera Wang - Crysta Papaya Spectacle - Kenmark Optical, Inc.

Duns Number:062952593

Device Description: Crysta Papaya Spectacle

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More Product Details

Catalog Number

-

Brand Name

Vera Wang

Version/Model Number

CRSTPA51

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

HQZ

Product Code Name

Frame, spectacle

Device Record Status

Public Device Record Key

545afc2f-d1e0-4456-bd05-cdb2bb89626f

Public Version Date

August 20, 2021

Public Version Number

1

DI Record Publish Date

August 12, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KENMARK OPTICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 15013