High Stakes Eyewear

GUDID 00812056033006

Eyeglass Frame,"High Roller,Brown/White,54"

ENCORE VISION, INC.

Prescription spectacles Prescription spectacles Prescription spectacles Prescription spectacles Prescription spectacles Prescription spectacles Prescription spectacles Prescription spectacles
Primary Device ID00812056033006
NIH Device Record Keyaa14c8ef-102b-4a52-b66e-e9d8f739ae96
Commercial Distribution StatusIn Commercial Distribution
Brand NameHigh Stakes Eyewear
Version Model NumberHigh Roller
Company DUNS154402791
Company NameENCORE VISION, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100812056033006 [Primary]

FDA Product Code

HQZFrame, Spectacle

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-24
Device Publish Date2022-06-16

On-Brand Devices [High Stakes Eyewear]

00812056033006Eyeglass Frame,"High Roller,Brown/White,54"
00812056032993Eyeglass Frame,"High Roller,Black/White,54"
00812056033563Eyeglass Frame,"High Roller,Purple/Silver,54"

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