High Flow Viscous Fluid Extraction Suitable for 20/23/25/27G DORC Cannula System 1362.VFE

GUDID 18717872007158

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

Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Primary Device ID18717872007158
NIH Device Record Key28d7f15c-a19a-4e50-819b-3196d15511dc
Commercial Distribution StatusIn Commercial Distribution
Brand NameHigh Flow Viscous Fluid Extraction Suitable for 20/23/25/27G DORC Cannula System
Version Model Number1362.VFE
Catalog Number1362.VFE
Company DUNS407522184
Company NameD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Device Count5
DM Exemptfalse
Pre-market Exempttrue
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
GS108717872007151 [Primary]
GS118717872007158 [Unit of Use]

FDA Product Code

KYGDevice, Irrigation, Ocular Surgery

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-19
Device Publish Date2021-02-11

On-Brand Devices [High Flow Viscous Fluid Extraction Suitable for 20/23/25/27G DORC Cannula System]

187178720071581362.VFE
187178720196251362.VFE

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