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Z Cartridge IOL Delivery System - Cartridge

FDA UDI

Class I (US FDA UDI)

by Carl Zeiss Meditec Production, LLC

Identity

Trade Name
Z Cartridge IOL Delivery System - Cartridge FDA UDI
Generic Name
Intraocular lens-insertion cartridge FDA UDI
Model / Reference
Z28 FDA UDI

Identifiers

Catalog Number
003500-0047-251 FDA UDI
Primary DI / UDI-DI
00843045101833 FDA UDI
510(k) Number
K123888 FDA UDI
FDA Product Code
MSS FDA UDI
GMDN Term
Intraocular lens-insertion cartridge 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Intraocular lens-insertion cartridge

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

Similar devices

Also classified as Intraocular lens-insertion cartridge.

Cleared under the same submission

K123888 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Carl Zeiss Meditec Production, LLC

Sources (1)

  • FDA UDI f79a5af4-6873-4409-9994-ae1da6344221 34 fields · synced May 30, 2026