ONSI-56

GUDID 00858174006041

ONSI-56 Fluoro-silicone acrylate daily wear contact lens

LAGADO CORPORATION, THE

Rigid-gas-permeable corrective contact lens, daily-wear
Primary Device ID00858174006041
NIH Device Record Key8040017f-eda6-42af-a9ab-c74429140106
Commercial Distribution StatusIn Commercial Distribution
Brand NameONSI-56
Version Model Number041
Company DUNS109884150
Company NameLAGADO CORPORATION, THE
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100858174006041 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HQDLens, Contact (Other Material) - Daily

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-04

Devices Manufactured by LAGADO CORPORATION, THE

00858174006003 - PMMA2018-07-06 PMMA (polymethyl methacrylate) hard contact lens for daily wear
00858174006010 - SA-182018-07-06 SA-18 Silicone Acrylate daily wear contact lens
00858174006027 - SA-322018-07-06 SA-32 Fluoro-silicone Acrylate daily wear contact lens
00858174006034 - FLOSI2018-07-06 FLOSI Fuoro-silicone Acrylat daily wear contact lens
00858174006041 - ONSI-562018-07-06ONSI-56 Fluoro-silicone acrylate daily wear contact lens
00858174006041 - ONSI-562018-07-06 ONSI-56 Fluoro-silicone acrylate daily wear contact lens
00858174006058 - TYRO-972018-03-29 TYRO-97 Fluoro-silicone acrylate daily wear contact lens
00858174006522 - OP-22018-03-29 OP-2 Fluoro-silicone Acrylate daily wear contact lens
00858174006539 - OP-32018-03-29 OP-3 Fluoro-silicone Acrylate daily wear contact lens

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