2.2 mm Disposable phaco set with 30° straight flared needle 8430.22SF1

GUDID 18717872031450

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

Phacoemulsification system handpiece tip, single-use
Primary Device ID18717872031450
NIH Device Record Key5b9e4249-461e-411e-819d-0959954b53a4
Commercial Distribution StatusIn Commercial Distribution
Brand Name2.2 mm Disposable phaco set with 30° straight flared needle
Version Model Number8430.22SF1
Catalog Number8430.22SF1
Company DUNS407522184
Company NameD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Device Count6
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 Datefalse
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
GS108717872031453 [Primary]
GS118717872031450 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HQCUnit, Phacofragmentation

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-03-19
Device Publish Date2020-02-17

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

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