PHACO TIP WRENCH

GUDID 04049539100177

This re-usable device is an accessory for ZEISS phaco systems. It has been designed to screw and unscrew the tips to the phaco handpiece during human eye surgery.

Carl Zeiss Meditec AG

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Primary Device ID	04049539100177
NIH Device Record Key	825b4988-b8da-4f1b-a419-fe9cee95b612
Commercial Distribution Status	In Commercial Distribution
Brand Name	PHACO TIP WRENCH
Version Model Number	303060-0121-000
Company DUNS	342228620
Company Name	Carl Zeiss Meditec AG
Device Count	1
DM Exempt	true
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04049539100177 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K212241

FDA Product Code

NKX	Needle, Phacoemulsification, Reprocessed