Phaco Sure Touch Handpiece 3002.P

GUDID 08717872022437

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

Phacoemulsification system handpiece
Primary Device ID08717872022437
NIH Device Record Key2403f3a4-813b-40ee-99e3-93496b6866cb
Commercial Distribution StatusIn Commercial Distribution
Brand NamePhaco Sure Touch Handpiece
Version Model Number3002.P
Catalog Number3002.P
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
GS108717872022437 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HQCUnit, Phacofragmentation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08717872022437]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-14
Device Publish Date2020-02-06

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.