EVA Dust Cover. Accessory to EVA. 8000.DUC01

GUDID 08717872019185

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

Phacoemulsification/vitrectomy system
Primary Device ID08717872019185
NIH Device Record Key7d894b73-3dc0-49d8-984b-be50d988fbb0
Commercial Distribution StatusIn Commercial Distribution
Brand NameEVA Dust Cover. Accessory to EVA.
Version Model Number8000.DUC01
Catalog Number8000.DUC01
Company DUNS407522184
Company NameD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Device Count1
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
GS108717872019185 [Primary]

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 Number4
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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