Z Cartridge IOL Delivery System - Handpiece 003500-0047-252

GUDID 00843045101840

CARL ZEISS MEDITEC PRODUCTION, LLC

Manual intraocular lens injector, reusable
Primary Device ID00843045101840
NIH Device Record Keyd09c7745-bf0f-4916-bacb-083828b52264
Commercial Distribution StatusIn Commercial Distribution
Brand NameZ Cartridge IOL Delivery System - Handpiece
Version Model NumberR28
Catalog Number003500-0047-252
Company DUNS080685425
Company NameCARL ZEISS MEDITEC PRODUCTION, LLC
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 Usefalse
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
GS100843045101840 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MSSFolders And Injectors, Intraocular Lens (Iol)

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00843045101840]

Moist Heat or Steam Sterilization


[00843045101840]

Moist Heat or Steam Sterilization


[00843045101840]

Moist Heat or Steam Sterilization


[00843045101840]

Moist Heat or Steam Sterilization


[00843045101840]

Moist Heat or Steam Sterilization


[00843045101840]

Moist Heat or Steam Sterilization


[00843045101840]

Moist Heat or Steam Sterilization


[00843045101840]

Moist Heat or Steam Sterilization


[00843045101840]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-10-10
Device Publish Date2018-09-07

Devices Manufactured by CARL ZEISS MEDITEC PRODUCTION, LLC

00843045101888 - CT LUCIA2023-03-06 1-piece, monofocal, hydrophobic, acrylic, intraocular lens, +00.0D
00843045101895 - CT LUCIA2023-03-06 1-piece, monofocal, hydrophobic, acrylic, intraocular lens, +00.5D
00843045101901 - CT LUCIA2023-03-06 1-piece, monofocal, hydrophobic, acrylic, intraocular lens, +01.0D
00843045101918 - CT LUCIA2023-03-06 1-piece, monofocal, hydrophobic, acrylic, intraocular lens, +01.5D
00843045101925 - CT LUCIA2023-03-06 1-piece, monofocal, hydrophobic, acrylic, intraocular lens, +02.0D
00843045101932 - CT LUCIA2023-03-06 1-piece, monofocal, hydrophobic, acrylic, intraocular lens, +02.5D
00843045101949 - CT LUCIA2023-03-06 1-piece, monofocal, hydrophobic, acrylic, intraocular lens, +03.0D
00843045101956 - CT LUCIA2023-03-06 1-piece, monofocal, hydrophobic, acrylic, intraocular lens, +03.5D

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