2.8 mm Reusable phaco set with 30° straight flared needle 3430.28SF1

GUDID 18717872031559

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

Phacoemulsification system handpiece
Primary Device ID18717872031559
NIH Device Record Keyc96f3981-87f5-41eb-8076-c14e4c809f92
Commercial Distribution StatusIn Commercial Distribution
Brand Name2.8 mm Reusable phaco set with 30° straight flared needle
Version Model Number3430.28SF1
Catalog Number3430.28SF1
Company DUNS407522184
Company NameD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Device Count6
DM Exempttrue
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
GS108717872031552 [Primary]
GS118717872031559 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HQCUnit, Phacofragmentation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[18717872031559]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-03-19
Device Publish Date2020-02-10

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

18717872034932 - 23G High Flow infusion line2024-02-29
18717872034949 - 25G High Flow infusion line2024-02-29
18717872034956 - 27G High Flow infusion line2024-02-29
18717872035106 - EVA NEXUS™ Posterior 23G TDC Pack2024-02-29
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.