Combined 23G Eckardt Multi-Fiber Endoillumination Probe / Chandelier (23 gauge /

GUDID 18717872035595

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

Ophthalmic fibreoptic light instrument, single-use
Primary Device ID18717872035595
NIH Device Record Keycd97647a-16af-4769-a11d-d2b6f179636e
Commercial Distribution StatusIn Commercial Distribution
Brand NameCombined 23G Eckardt Multi-Fiber Endoillumination Probe / Chandelier (23 gauge /
Version Model Number3269.MF06-00
Company DUNS407522184
Company NameD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Device Count6
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
GS108717872035598 [Primary]
GS118717872035595 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MPAEndoilluminator

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-08
Device Publish Date2025-03-31

On-Brand Devices [Combined 23G Eckardt Multi-Fiber Endoillumination Probe / Chandelier (23 gauge /]

087178720196043269.MF06
187178720355953269.MF06-00

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