Vented Global Pressure Control Set to be used with Associate Cartridge 1250.VGPC

GUDID 08717872017594

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

Surgical irrigation/aspiration tubing set
Primary Device ID08717872017594
NIH Device Record Key8c732d1f-7646-4050-a094-318c0db31729
Commercial Distribution StatusIn Commercial Distribution
Brand NameVented Global Pressure Control Set to be used with Associate Cartridge
Version Model Number1250.VGPC
Catalog Number1250.VGPC
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
GS108717872017594 [Primary]
GS118717872007592 [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 Date2021-03-15
Device Publish Date2016-09-23

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