EVA Mayo Arm. Accessory to EVA. 8000.MAY01

GUDID 08717872019673

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

Phacoemulsification/vitrectomy system
Primary Device ID08717872019673
NIH Device Record Keycd343cb8-f641-45c5-ac2e-e01e98168c0f
Commercial Distribution StatusIn Commercial Distribution
Brand NameEVA Mayo Arm. Accessory to EVA.
Version Model Number8000.MAY01
Catalog Number8000.MAY01
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 Numbertrue
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
GS108717872019673 [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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18717872035311 - EVA NEXUS™ Posterior 25G TDC Pack2024-02-29

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