Disposable High Speed Cutter 20G/8000CPM 8267.VIT20

GUDID 08717872019109

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

Ophthalmic surgical instrument handle, pneumatic
Primary Device ID08717872019109
NIH Device Record Keyd80faa28-c83e-45fc-8e3c-9e10acf24810
Commercial Distribution StatusIn Commercial Distribution
Brand NameDisposable High Speed Cutter 20G/8000CPM
Version Model Number8267.VIT20
Catalog Number8267.VIT20
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
GS108717872019109 [Primary]
GS118717872019106 [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 Number5
Public Version Date2020-03-19
Device Publish Date2016-09-23

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

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