RxLAL Post Op Spectacles

GUDID 00818806020500

Post Op Spectacles, Large

RXSIGHT, INC.

Tinted spectacle lens, non-prescription
Primary Device ID00818806020500
NIH Device Record Key8cc31c4d-40bc-41d6-a397-0621f2e40ce9
Commercial Distribution StatusIn Commercial Distribution
Brand NameRxLAL Post Op Spectacles
Version Model Number62016-002
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
GS100818806020500 [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 Date2019-05-10
Device Publish Date2019-05-02

On-Brand Devices [RxLAL Post Op Spectacles]

00818806020487Post Op Spectacles
00818806020326Post Op Spectacles
00818806020500Post Op Spectacles, Large
00818806020494Post Op Spectacles

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