Disposable I/A replacement Tubing set for REF: 6279.ASD1 Cartridge, including co 6279.ASD2

GUDID 08717872013428

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

Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set
Primary Device ID08717872013428
NIH Device Record Key03455a9e-2e08-4388-be09-423d2442e836
Commercial Distribution StatusIn Commercial Distribution
Brand NameDisposable I/A replacement Tubing set for REF: 6279.ASD1 Cartridge, including co
Version Model Number6279.ASD2
Catalog Number6279.ASD2
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
GS108717872013428 [Primary]
GS118717872013425 [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

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

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