Boston Equalens Boston Equalens

GUDID 00785811435622

Rigid Gas Permeable Contact Lens

BAUSCH & LOMB INCORPORATED

Rigid-gas-permeable corrective contact lens, extended-wear Rigid-gas-permeable corrective contact lens, extended-wear
Primary Device ID00785811435622
NIH Device Record Key2bc5126f-32be-4d54-8cd2-365d05171056
Commercial Distribution StatusIn Commercial Distribution
Brand NameBoston Equalens
Version Model Numberitaflurofocon A
Catalog NumberBoston Equalens
Company DUNS058816302
Company NameBAUSCH & LOMB INCORPORATED
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
GS100785811435622 [Primary]

FDA Product Code

MWLLens,Contact(Rigid Gas Permeable)-Extended Wear

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-10-18

Devices Manufactured by BAUSCH & LOMB INCORPORATED

00757770520183 - BLIS-X12024-03-12 BLIS IOL Delivery System – X1 Cartridge
00757770523337 - BLIS-X02024-03-12 BLIS IOL Delivery System – X0 Cartridge
00757770601745 - Optisol2024-03-12 CORNEAL STORAGE MEDIA (Box of 12)
00757770488964 - Cystalsert Delivery System2024-01-26 Inserter - Lens Delivery System
00757770529032 - Sofport Easy-Load Lens Delivery System EZ-242024-01-26 Inserter - Lens Delivery System
10757770618887 - enVista Aspire toric IOL2023-11-27 enVista Aspire toric hydrophobic acrylic IOL (non-preloaded) +8.00D SE / +1.50D CYL
10757770618894 - enVista Aspire toric IOL2023-11-27 enVista Aspire toric hydrophobic acrylic IOL (non-preloaded) +8.50D SE / +1.50D CYL
10757770618900 - enVista Aspire toric IOL2023-11-27 enVista Aspire toric hydrophobic acrylic IOL (non-preloaded) +9.00D SE / +1.50D CYL

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