Post Op Eyewear

GUDID 00818806021750

Post Op Spectacles Kit

RXSIGHT, INC.

Tinted non-prescription spectacle lens
Primary Device ID00818806021750
NIH Device Record Keya82dcdfa-08c9-487b-8f9f-89e8203237e5
Commercial Distribution StatusIn Commercial Distribution
Brand NamePost Op Eyewear
Version Model Number62026
Company DUNS052054413
Company NameRXSIGHT, 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 Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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
GS100818806021750 [Primary]

FDA Product Code

HQYSunglasses (Non-Prescription Including Photosensitive)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-15
Device Publish Date2025-09-05

On-Brand Devices [Post Op Eyewear]

00818806021767Post Op Spectacles, +1.50D
00818806021750Post Op Spectacles Kit

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