PHACO SET PLUS 21G,BICONICAL,15°

GUDID 04049539103871

This single use device is an accessory for ZEISS phaco systems. It has been designed to emulsify and aspirate the eye lens during human cataract surgery. (consists of TEST CHAMBER, PHACO TIP and SILICONE SLEEVE).

Carl Zeiss Meditec AG

Ophthalmic surgical procedure kit, non-medicated, single-use
Primary Device ID04049539103871
NIH Device Record Key95268840-d67f-49fe-884a-4a1d922d5262
Commercial Distribution StatusIn Commercial Distribution
Brand NamePHACO SET PLUS 21G,BICONICAL,15°
Version Model Number303060-1023-000
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 Kittrue
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
GS104049539102492 [Primary]
GS104049539103871 [Package]
Contains: 04049539102492
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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