UV Spectacle Kit

GUDID 00818806020883

UV Spectacle Kit

RXSIGHT, INC.

Tinted spectacle lens, non-prescription Tinted spectacle lens, non-prescription Tinted spectacle lens, non-prescription Tinted spectacle lens, non-prescription Tinted spectacle lens, non-prescription Tinted spectacle lens, non-prescription Tinted spectacle lens, non-prescription Tinted spectacle lens, non-prescription Tinted spectacle lens, non-prescription Tinted spectacle lens, non-prescription Tinted spectacle lens, non-prescription Tinted spectacle lens, non-prescription Tinted spectacle lens, non-prescription Tinted spectacle lens, non-prescription Tinted non-prescription spectacle lens Tinted non-prescription spectacle lens Tinted non-prescription spectacle lens Tinted non-prescription spectacle lens Tinted non-prescription spectacle lens Tinted non-prescription spectacle lens Tinted non-prescription spectacle lens
Primary Device ID00818806020883
NIH Device Record Key320d9d29-e6e8-4857-85bb-5c86800b0dde
Commercial Distribution StatusIn Commercial Distribution
Brand NameUV Spectacle Kit
Version Model Number62023
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
GS100818806020883 [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 Date2020-10-08
Device Publish Date2020-09-30

Devices Manufactured by RXSIGHT, INC.

00818806021378 - Light Adjustable Lens (LAL)2023-05-09 LAL+, Light Adjustable Lens, Sterile, Packaged, 4.0 Diopter
00818806021385 - Light Adjustable Lens (LAL)2023-05-09 LAL+, Light Adjustable Lens, Sterile, Packaged, 5.0 Diopter
00818806021392 - Light Adjustable Lens (LAL)2023-05-09 LAL+, Light Adjustable Lens, Sterile, Packaged, 6.0 Diopter
00818806021408 - Light Adjustable Lens (LAL)2023-05-09 LAL+, Light Adjustable Lens, Sterile, Packaged, 7.0 Diopter
00818806021415 - Light Adjustable Lens (LAL)2023-05-09 LAL+, Light Adjustable Lens, Sterile, Packaged, 8.0 Diopter
00818806021422 - Light Adjustable Lens (LAL)2023-05-09 LAL+, Light Adjustable Lens, Sterile, Packaged, 9.0 Diopter
00818806021439 - Light Adjustable Lens (LAL)2023-05-09 LAL, Sterile, Packaged, 5.0 Diopter
00818806021446 - Light Adjustable Lens (LAL)2023-05-09 LAL+, Light Adjustable Lens, Sterile, Packaged, 11.0 Diopter

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