Home GUDID 00380659777745 Monarch
Primary DI 00380659777745
Brand Monarch
Company Alcon Laboratories, Inc.
Model 00380659777745
Device description Clareon Monarch IV IOL Delivery System for use with Clareon only
Published 2021-11-11
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name MSS Folders and injectors, intraocular lens (iol)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MSS Folders And Injectors, Intraocular Lens (Iol) Ophthalmic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00380659777745 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00380659777745 00380659777745 380659777745 0380659777745
GMDN Terms# Term, Definition table Term Definition Manual intraocular lens injector, reusable A hand-held, manual, ophthalmic surgical instrument designed to expel (launch) a prepared folded intraocular lens (IOL) from an attached IOL insertion cartridge into the anterior or posterior chamber of the eye during ophthalmic surgery. Commonly known as the handpiece, this device is used to carefully exert pressure on the prepared IOL to push it out of the IOL insertion cartridge. It is typically made of lightweight metal materials [e.g., titanium (Ti)], has a central plunger that is activated by a precise mechanism (e.g., a screw thread), and has a mechanism at the distal end to hold/grip the insertion cartridge. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 008018525 Device count 1 Lot or batch true Serial number true Manufacturing date on label true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 07612717071582 FINESSE REFLEX 806.43 2022-06-22 07612717071612 FINESSE REFLEX 806.44 2022-06-22 07612717071629 FINESSE REFLEX 806.45 2022-06-22 07612717071636 FINESSE REFLEX 806.47 2022-06-22 00380657410859 Alcon, Infiniti, MicroSmooth, ABS 8065741085 2016-09-24 00380657410873 Alcon, Infiniti, MicroSmooth, Kelman, ABS 8065741087 2016-09-24 00380657410972 Alcon, Infiniti, MicroSmooth, ABS 8065741097 2016-09-24 00380657502806 Alcon, Infiniti, MicroSmooth, ABS 8065750280 2016-09-24 00380657517190 Alcon, Infiniti, Intrepid, ABS 8065751719 2016-09-24 00380657520886 Alcon, Infiniti, Intrepid 8065752088 2016-09-24 00300650193108 OPTI-FREE EXPRESS OPTI-FREE EXPRESS 10ml 2016-09-24 00300650193207 OPTI-FREE EXPRESS OPTI-FREE EXPRESS 20ml 2016-09-24 00380657402601 Alcon 8065740260 2016-09-24 00380652268899 ACRYSOF, IQ RESTOR SND1T3 SND1T3U130 2017-02-24 00380658552008 Clareon TruPlus REYWT8 REYWT8.250 2026-05-14 00380658552015 Clareon TruPlus REYWT8 REYWT8.255 2026-05-14 00380658552022 Clareon TruPlus REYWT8 REYWT8.260 2026-05-14 00380658552039 Clareon TruPlus REYWT8 REYWT8.265 2026-05-14 00380658552046 Clareon TruPlus REYWT8 REYWT8.270 2026-05-14 00380658552053 Clareon TruPlus REYWT8 REYWT8.275 2026-05-14
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