EV Collection

GUDID 00812056033686

Eyeglass Frame,"EV300, Brown/Aqua, 53-16-145"

ENCORE VISION, INC.

Prescription spectacles
Primary Device ID00812056033686
NIH Device Record Key841d331c-6d5a-4aad-b8e0-892e81c979dd
Commercial Distribution StatusIn Commercial Distribution
Brand NameEV Collection
Version Model NumberEV300
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
GS100812056033686 [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 Date2022-07-04
Device Publish Date2022-06-24

On-Brand Devices [EV Collection]

00812056033730Eyeglass Frame,"EV302, Brown/Aqua, 54-19-142"
00812056033723Eyeglass Frame,"EV302, Crystal/Black, 54-19-142"
00812056033716Eyeglass Frame,"EV301, Purple, 51-18-145"
00812056033709Eyeglass Frame,"EV301, Grey, 51-18-145"
00812056033693Eyeglass Frame,"EV300, Black/Crystal, 53-16-145"
00812056033686Eyeglass Frame,"EV300, Brown/Aqua, 53-16-145"

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