Superflex Collection

GUDID 00676190315059

WestGroupe Optical Inc

Spectacle frame Spectacle frame Spectacle frame Spectacle frame Spectacle frame Spectacle frame Spectacle frame Spectacle frame Spectacle frame Spectacle frame Spectacle frame Spectacle frame Spectacle frame Spectacle frame
Primary Device ID00676190315059
NIH Device Record Key8ebd3276-e095-4e2c-b3c7-ec07c7bc396f
Commercial Distribution StatusIn Commercial Distribution
Brand NameSuperflex Collection
Version Model NumberSF-512 BROWN
Company DUNS204096080
Company NameWestGroupe Optical 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 Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100676190315059 [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 Date2020-07-17
Device Publish Date2020-07-09

On-Brand Devices [Superflex Collection]

00676190322798SF-520 BROWN
00676190322637SF-519 BROWN TAUPE
00676190322590SF-519 BROWN TAUPE
00676190322552SF-519 BLUE GUN
00676190322514SF-519 BLUE GUN
00676190322477SF-519 BLACK GUN
00676190322439SF-519 BLACK GUN
00676190322392SF-518 TOKYO TORTOISE
00676190322354SF-518 TOKYO TORTOISE
00676190322316SF-518 NAVY
00676190322194SF-518 BLACK
00676190322156SF-521 NAVY AQUA
00676190322118SF-521 NAVY AQUA
00676190322071SF-521 MAROON YELLOW
00676190322033SF-521 MAROON YELLOW
00676190321999SF-521 BLACK RED
00676190321951SF-521 BLACK RED
00676190315332SF-515 BLUE
00676190315257SF-515 GUN
00676190315219SF-515 GUN
00676190315172SF-515 BROWN
00676190315097SF-512 BROWN
00676190315059SF-512 BROWN
00676190315011SF-512 GREY
00676190314977SF-512 GREY
00676190314939SF-512 NAVY
00676190314892SF-512 NAVY
00676190314854SF-516 BLACK
00676190314816SF-516 BLACK
00676190314779SF-516 INK
00676190314731SF-516 INK
00676190314694SF-516 BROWN
00676190314656SF-516 BROWN
00676190314458SF-514 BROWN
00676190314410SF-514 BROWN
00676190314373SF-514 BLACK
00676190314335SF-514 BLACK
00676190314298SF-514 DARK GUN
00676190314250SF-514 DARK GUN
00676190314212SF-513 TORTOISE
00676190314175SF-513 TORTOISE
00676190314137SF-513 BLUE
00676190314052SF-513 BLACK
00676190314014SF-513 BLACK
00676190311419SF-509 BROWN ORANGE
00676190311372SF-509 BROWN ORANGE
00676190311259SF-509 BLACK RED
00676190311211SF-509 BLACK RED
00676190310689SF-510 DARK TAUPE
00676190310641SF-510 DARK TAUPE

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