Z Cartridge IOL Delivery System - Handpiece

FDA UDI

Class I (US FDA UDI)

by Carl Zeiss Meditec Production, LLC

Identity

Trade Name: Z Cartridge IOL Delivery System - Handpiece FDA UDI
Generic Name: Manual intraocular lens injector, reusable FDA UDI
Model / Reference: R28 FDA UDI

Identifiers

Catalog Number: 003500-0047-252 FDA UDI
Primary DI / UDI-DI: 00843045101840 FDA UDI
510(k) Number: K123888 FDA UDI
FDA Product Code: MSS FDA UDI
GMDN Term: Manual intraocular lens injector, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 886.4300 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Manual intraocular lens injector, reusable

Z Cartridge IOL Delivery System - Handpiece by Carl Zeiss Meditec Production, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K123888 also covers:

Z Cartridge IOL Delivery System - Cartridge — Carl Zeiss Meditec Production, LLC

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Carl Zeiss Meditec Production, LLC

Sources (1)

FDA UDI d09c7745-bf0f-4916-bacb-083828b52264 34 fields · synced Jun 8, 2026