Ethan Henry (Elasticity)

GUDID 00812056030128

Eyeglass Frame,"EL600, Black/Lime, 55-17-145"

ENCORE VISION, INC.

Prescription spectacles
Primary Device ID00812056030128
NIH Device Record Key8d66dcff-2c27-4559-90e4-b863407a4192
Commercial Distribution StatusIn Commercial Distribution
Brand NameEthan Henry (Elasticity)
Version Model NumberEL600
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
GS100812056030128 [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 Date2022-07-01
Device Publish Date2022-06-23

On-Brand Devices [Ethan Henry (Elasticity)]

00812056030128Eyeglass Frame,"EL600, Black/Lime, 55-17-145"
00812056030111Eyeglass Frame,"EH600, Brown/Blue, 55-17-145"
00812056030104Eyeglass Frame,"EL600, Black/Dk. Blue, 55-17-145"

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