Disposable Drapes, for Associate touch screen & remote control. 6279.SD

GUDID 08717872013503

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

Ophthalmic surgical procedure kit, non-medicated, single-use
Primary Device ID08717872013503
NIH Device Record Key31b613b0-a73d-4be4-bee2-d11f2e4ca5cf
Commercial Distribution StatusIn Commercial Distribution
Brand NameDisposable Drapes, for Associate touch screen & remote control.
Version Model Number6279.SD
Catalog Number6279.SD
Company DUNS407522184
Company NameD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Device Count10
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
GS108717872013503 [Primary]
GS118717872013500 [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 StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-08
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.