EVA NEXUSTM Custom Phaco Pack 1.8mm 30 (Straight)

GUDID 18717872034307

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

Ophthalmic surgical procedure kit, non-medicated, single-use
Primary Device ID18717872034307
NIH Device Record Key8c984629-1d5e-4658-b3ee-20c6b5530987
Commercial Distribution StatusIn Commercial Distribution
Brand NameEVA NEXUSTM Custom Phaco Pack 1.8mm 30 (Straight)
Version Model Number9530.18SF1
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
GS108717872034300 [Primary]
GS118717872034307 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-17
Device Publish Date2022-10-07

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

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