Test chamber for phaco handpiece 3007

GUDID 08717872009230

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

Phacoemulsification system handpiece
Primary Device ID08717872009230
NIH Device Record Keyaab68ebc-b8a1-4113-b659-545218fb43f4
Commercial Distribution StatusIn Commercial Distribution
Brand NameTest chamber for phaco handpiece
Version Model Number3007
Catalog Number3007
Company DUNS407522184
Company NameD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Device Count1
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
GS108717872009230 [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 Number5
Public Version Date2020-03-18
Device Publish Date2016-09-23

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

18717872034710 - CUSTOM TDC VITREC.PACK VGP 25G2024-10-07
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

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