Scleral Buckling Product Style 106, Meridional Implant - 10.5mm 92-26

GUDID 18717872014484

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

Scleral buckling device, non-bioabsorbable
Primary Device ID18717872014484
NIH Device Record Key425b658a-014e-4d74-8f50-74018adbca8b
Commercial Distribution StatusIn Commercial Distribution
Brand NameScleral Buckling Product Style 106, Meridional Implant - 10.5mm
Version Model Number92-26
Catalog Number92-26
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 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
GS108717872014487 [Primary]
GS118717872014484 [Package]
Contains: 08717872014487
Package: box [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HQXImplant, Orbital, Extra-Ocular

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-12-22
Device Publish Date2020-11-16

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.