Directional Laser Probe with DORC connector.(25 gauge / 0.5 mm)

GUDID 18717872014965

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

Ophthalmic laser system beam guide
Primary Device ID18717872014965
NIH Device Record Key73187aca-e7cd-47e0-b8ab-3dd386d93b46
Commercial Distribution StatusIn Commercial Distribution
Brand NameDirectional Laser Probe with DORC connector.(25 gauge / 0.5 mm)
Version Model Number7225.DORC
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
GS108717872014968 [Primary]
GS118717872014965 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HQFLaser, Ophthalmic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-07-11
Device Publish Date2022-07-01

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