Post Op Spectacles

GUDID 00818806020463

Post Op Spectacles, +2.00

RXSIGHT, INC.

Tinted spectacle lens, non-prescription
Primary Device ID00818806020463
NIH Device Record Key9d6b7581-5af7-4142-97c0-3f4cba5c8b0f
Commercial Distribution StatusIn Commercial Distribution
Brand NamePost Op Spectacles
Version Model Number62015-002
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 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
GS100818806020463 [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 Date2019-04-16
Device Publish Date2019-04-08

On-Brand Devices [Post Op Spectacles]

00818806020470Post Op Spectacles, +2.50
00818806020463Post Op Spectacles, +2.00
00818806020456Post Op Spectacles, +1.50

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.