Universal PVC infusion line for 23G cannula system for VFI/VFE 1279.VFI

GUDID 08717872003351

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

Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Primary Device ID08717872003351
NIH Device Record Key0a28af0c-2129-4b16-9de3-212a5e1c4e29
Commercial Distribution StatusIn Commercial Distribution
Brand NameUniversal PVC infusion line for 23G cannula system for VFI/VFE
Version Model Number1279.VFI
Catalog Number1279.VFI
Company DUNS407522184
Company NameD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Device Count5
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
GS108717872003351 [Primary]
GS118717872003358 [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 Number9
Public Version Date2020-03-19
Device Publish Date2016-09-24

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

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