EVA Flight Case. Accessory to EVA. 8000.FLC01

GUDID 08717872020747

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

Phacoemulsification/vitrectomy system
Primary Device ID08717872020747
NIH Device Record Key11f01619-5430-46eb-a516-cfd982a5f539
Commercial Distribution StatusIn Commercial Distribution
Brand NameEVA Flight Case. Accessory to EVA.
Version Model Number8000.FLC01
Catalog Number8000.FLC01
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
GS108717872020747 [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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18717872035113 - EVA NEXUS™ Posterior 25G TDC Pack2024-02-29
18717872035120 - EVA NEXUS™ Posterior 27G TDC Pack2024-02-29
18717872035304 - EVA NEXUS™ Posterior 23G TDC Pack2024-02-29
18717872035311 - EVA NEXUS™ Posterior 25G TDC Pack2024-02-29

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