FDA.reportPublic FDA data

Z Cartridge IOL Delivery System - Handpiece

Primary DI
00843045101840
Brand
Z Cartridge IOL Delivery System - Handpiece
Company
CARL ZEISS MEDITEC PRODUCTION, LLC
Model
R28
Catalog number
003500-0047-252
Published
2018-09-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MSSFolders And Injectors, Intraocular Lens (Iol)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MSSFolders And Injectors, Intraocular Lens (Iol)Ophthalmic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123888000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123888000Z CARTRIDGE IOL DELIVERY SYSTEMAaren Scientific, Inc.2013-04-15MSS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00843045101840PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843045101840008430451018408430451018400843045101840

GMDN Terms#

Term, Definition table
TermDefinition
Manual intraocular lens injector, reusableA 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
080685425
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00843045101888CT LUCIACT LUCIA 621P.AM DPT 00.0003500-0056-4222023-02-24
00843045101895CT LUCIACT LUCIA 621P.AM DPT 00.5003500-0056-4232023-02-24
00843045101901CT LUCIACT LUCIA 621P.AM DPT 01.0003500-0056-4242023-02-24
00843045101918CT LUCIACT LUCIA 621P.AM DPT 01.5003500-0056-4252023-02-24
00843045101925CT LUCIACT LUCIA 621P.AM DPT 02.0003500-0056-4262023-02-24
00843045101932CT LUCIACT LUCIA 621P.AM DPT 02.5003500-0056-4272023-02-24
00843045101949CT LUCIACT LUCIA 621P.AM DPT 03.0003500-0056-4282023-02-24
00843045101956CT LUCIACT LUCIA 621P.AM DPT 03.5003500-0056-4292023-02-24
00843045101963CT LUCIACT LUCIA 621P.AM DPT 04.0003500-0056-4502023-02-24
00843045101970CT LUCIACT LUCIA 621P.AM DPT 04.5003500-0056-4512023-02-24
00843045101987CT LUCIACT LUCIA 621P.AM DPT 05.0003500-0056-4522023-02-24
00843045101994CT LUCIACT LUCIA 621P.AM DPT 05.5003500-0056-4532023-02-24
00843045102007CT LUCIACT LUCIA 621P.AM DPT 06.0003500-0056-4542023-02-24
00843045102014CT LUCIACT LUCIA 621P.AM DPT 06.5003500-0056-4552023-02-24
00843045102021CT LUCIACT LUCIA 621P.AM DPT 07.0003500-0056-4562023-02-24
00843045102038CT LUCIACT LUCIA 621P.AM DPT 07.5003500-0056-4572023-02-24
00843045102045CT LUCIACT LUCIA 621P.AM DPT 08.0003500-0056-4582023-02-24
00843045102052CT LUCIACT LUCIA 621P.AM DPT 08.5003500-0056-4592023-02-24
00843045102069CT LUCIACT LUCIA 621P.AM DPT 09.0003500-0056-4602023-02-24
00843045102076CT LUCIACT LUCIA 621P.AM DPT 09.5003500-0056-4612023-02-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10757770602497EyeGility™ InserterBausch & Lomb IncorporatedMSS2026-04-05
10757770618115EyeGility™ InserterBausch & Lomb IncorporatedMSS2026-04-05
10814899027454pioli™ IOL Delivery SystemAST PRODUCTS, INC.MSS2026-04-01
07630055212023ACCUJECT 2.2-1P INJECTOR SETMedicel AGMSS2025-12-09
07630055214584ACCUJECT injector Set 2.1-1PMedicel AGMSS2025-09-30
10818806021016RxSight Insertion DeviceRXSIGHT, INC.MSS2024-11-12
00818806021019RxSight Insertion DeviceRXSIGHT, INC.MSS2024-11-12
00844369016858I9011SLenstec Barbados IncMSS2024-05-06
00844369016865I9012Lenstec Barbados IncMSS2024-05-06
00844369016872I9012FSLenstec Barbados IncMSS2024-05-06
00844369018944LC16Lenstec Barbados IncMSS2024-05-06
00844369018968LC24Lenstec Barbados IncMSS2024-05-06
00844369018975CART45SLenstec Barbados IncMSS2024-05-06
00844369018982CARTMLenstec Barbados IncMSS2024-05-06
00757770520183BLIS-X1Bausch & Lomb IncorporatedMSS2024-03-04
00757770523337BLIS-X0Bausch & Lomb IncorporatedMSS2024-03-04
00757770488964Cystalsert Delivery SystemBausch & Lomb IncorporatedMSS2024-01-18
00757770529032Sofport Easy-Load Lens Delivery System EZ-24Bausch & Lomb IncorporatedMSS2024-01-18
07630055214850Accuject REFRA 2.9 InjectorMedicel AGMSS2023-12-08
07630055211934VISCOJECT 2.2 INJECTOR-SETMedicel AGMSS2023-12-01
07630055211941VISCOJECT 1.8 Injector setMedicel AGMSS2023-12-01
20840311300017MicroStaarSTAAR SURGICAL COMPANYMSS2023-06-15
20840311300024MicroStaarSTAAR SURGICAL COMPANYMSS2023-06-15
00840311344796MicroStaarSTAAR SURGICAL COMPANYMSS2023-06-15
00840311344802MicroStaarSTAAR SURGICAL COMPANYMSS2023-06-15
10840311300010MicroStaarSTAAR SURGICAL COMPANYMSS2023-06-15
10840311300027MicroStaarSTAAR SURGICAL COMPANYMSS2023-06-15
00840311300013MicroStaarSTAAR SURGICAL COMPANYMSS2023-06-15
00840311300020MicroStaarSTAAR SURGICAL COMPANYMSS2023-06-15
00841668142851ASICO ROYALE III INJECTOR W/ LONG SPRINGKATENA PRODUCTS, INC.MSS2022-12-13