ULITE PHACO HANDPIECE

GUDID 04049539100184

This active reusable device is an accessory for ZEISS phaco systems. It has been designed to emulsify and aspirate the eye lens during human eye surgery by phacoemulsification technique.

Carl Zeiss Meditec AG

Phacoemulsification system handpiece
Primary Device ID04049539100184
NIH Device Record Key75b0649c-c6d6-467e-b0c4-c70895e76997
Commercial Distribution StatusIn Commercial Distribution
Brand NameULITE PHACO HANDPIECE
Version Model Number303060-0001-000
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
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
GS104049539100184 [Primary]

FDA Product Code

HQCUnit, Phacofragmentation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04049539100184]

Moist Heat or Steam Sterilization


[04049539100184]

Moist Heat or Steam Sterilization


[04049539100184]

Moist Heat or Steam Sterilization


[04049539100184]

Moist Heat or Steam Sterilization


[04049539100184]

Moist Heat or Steam Sterilization


[04049539100184]

Moist Heat or Steam Sterilization


[04049539100184]

Moist Heat or Steam Sterilization


[04049539100184]

Moist Heat or Steam Sterilization


[04049539100184]

Moist Heat or Steam Sterilization


[04049539100184]

Moist Heat or Steam Sterilization


[04049539100184]

Moist Heat or Steam Sterilization


[04049539100184]

Moist Heat or Steam Sterilization


[04049539100184]

Moist Heat or Steam Sterilization


[04049539100184]

Moist Heat or Steam Sterilization


[04049539100184]

Moist Heat or Steam Sterilization


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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