IRR & ASP HANDPIECES BIMANUAL

GUDID 04049539102683

This single use device is an accessory for ZEISS phaco systems. It has been designed to remove the cortex and clean the capsule bag during human cataract surgery.

Carl Zeiss Meditec AG

Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Primary Device ID04049539102683
NIH Device Record Key8f603f62-e2a9-4cc5-9afb-744d90b07356
Commercial Distribution StatusIn Commercial Distribution
Brand NameIRR & ASP HANDPIECES BIMANUAL
Version Model Number303060-0165-000
Company DUNS342228620
Company NameCarl Zeiss Meditec AG
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104049539100191 [Primary]
GS104049539102683 [Package]
Contains: 04049539100191
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HQCUnit, Phacofragmentation

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-03
Device Publish Date2022-04-25

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04049471100167 - Treatment Pack (Type KP)2024-02-19 single use accessory for ZEISS femtosecond lasers
04049471100136 - Treatment Pack (Size S)2024-02-16 single use accessory for ZEISS femtosecond lasers
04049539101341 - EyeMag Smart2023-11-16
04049539101358 - EyeMag Pro S2023-11-16
04049539101365 - EyeMag Pro F2023-11-16
04049539064103 - PENTERO® 800 S 2023-09-19

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