Bead of My Heart

GUDID 00812056030012

Eyeglass Frame,"Mystical Frame, Brown/White, 54-18-140"

ENCORE VISION, INC.

Prescription spectacles
Primary Device ID00812056030012
NIH Device Record Key7d791e64-0dae-4a2b-a157-b1e7e6a2863d
Commercial Distribution StatusIn Commercial Distribution
Brand NameBead of My Heart
Version Model NumberMystical
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
GS100812056030012 [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 [Bead of My Heart]

00812056030029Eyeglass Frame,"Mystical Frame, Purple/Silver, 54-18-140 "
00812056030012Eyeglass Frame,"Mystical Frame, Brown/White, 54-18-140"
00812056030005Eyeglass Frame,"Mystical Frame, Black/White, 54-18-140 "

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