Touch screen pen. Accessory to the DORC Associate 6279.PEN

GUDID 08717872018263

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

Phacoemulsification/vitrectomy system generator
Primary Device ID08717872018263
NIH Device Record Keyc22c3fdb-2088-43de-85d1-4e0cd235e3e6
Commercial Distribution StatusIn Commercial Distribution
Brand NameTouch screen pen. Accessory to the DORC Associate
Version Model Number6279.PEN
Catalog Number6279.PEN
Company DUNS407522184
Company NameD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Device Count3
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108717872018263 [Primary]
GS118717872018260 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HQCUnit, Phacofragmentation

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

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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