Endoillumination Probe, including illuminated scleral depressor. (27 gauge / 0.4 3269.D04

GUDID 08717872018577

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

Ophthalmic fibreoptic light instrument, single-use
Primary Device ID08717872018577
NIH Device Record Keya120dc5e-f5fc-4f6c-b186-8972e53ceea4
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndoillumination Probe, including illuminated scleral depressor. (27 gauge / 0.4
Version Model Number3269.D04
Catalog Number3269.D04
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
GS108717872018577 [Primary]
GS118717872018574 [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 StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-05-07
Device Publish Date2016-09-23

On-Brand Devices [Endoillumination Probe, including illuminated scleral depressor. (27 gauge / 0.4]

087178720185773269.D04
087178720298323269.D04

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