Spectacle Lens

GUDID 06974852470073

Luxin Optical (Shanghai) Co., Ltd.

Prescription spectacles
Primary Device ID06974852470073
NIH Device Record Key1bb68be6-161e-49db-bad2-ebc8e46a6537
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpectacle Lens
Version Model NumberLXPAC
Company DUNS527864061
Company NameLuxin Optical (Shanghai) Co., Ltd.
Device Count10
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 Batchtrue
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
GS106974852470073 [Unit of Use]
GS116974852470070 [Primary]

FDA Product Code

HQGLens, Spectacle, Non-Custom (Prescription)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-17
Device Publish Date2023-03-09

Devices Manufactured by Luxin Optical (Shanghai) Co., Ltd.

06974852470189 - Sunglasses2023-03-20
16974852470018 - Spectacle Frame2023-03-17
06974852470073 - Spectacle Lens2023-03-17
06974852470073 - Spectacle Lens2023-03-17
06974852470127 - Reading glasses2023-03-17

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