2.4 mm Reusable phaco set with 45° angled flared needle Note: Maximum 20x reusab

GUDID 18717872033331

D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.

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Primary Device ID	18717872033331
NIH Device Record Key	fd8fde34-c033-43eb-98e7-a913ece80bb7
Commercial Distribution Status	In Commercial Distribution
Brand Name	2.4 mm Reusable phaco set with 45° angled flared needle Note: Maximum 20x reusab
Version Model Number	3445.24AF1
Company DUNS	407522184
Company Name	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Device Count	6
DM Exempt	false
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	false
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	08717872033334 [Primary]
GS1	18717872033331 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K190875

FDA Product Code

HQC	Unit, Phacofragmentation