25ga Stiff Illuminated MultiFlex™ Extendable Laser Probe, Iridex Connector

GUDID 10817489027704

KATALYST SURGICAL LLC

Ophthalmic laser system beam guide
Primary Device ID10817489027704
NIH Device Record Keyf5f0f2d5-5fa5-4905-aa57-1cc51953d4d5
Commercial Distribution StatusIn Commercial Distribution
Brand Name25ga Stiff Illuminated MultiFlex™ Extendable Laser Probe, Iridex Connector
Version Model NumberV6351E-25AR
Company DUNS007883297
Company NameKATALYST SURGICAL LLC
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 Datetrue
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
GS100817489027707 [Unit of Use]
GS110817489027704 [Primary]

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 Date2019-04-11
Device Publish Date2019-04-03

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