23ga MultiFlex™ Extendable Laser Probe, Iridex Connector

GUDID 10817489026615

23ga MultiFlex™ Extendable Laser Probe, Iridex Connector

KATALYST SURGICAL LLC

Ophthalmic fibreoptic light instrument, single-use
Primary Device ID10817489026615
NIH Device Record Key0f0899a7-3368-480f-aba8-76c6d0d1bae4
Commercial Distribution StatusIn Commercial Distribution
Brand Name23ga MultiFlex™ Extendable Laser Probe, Iridex Connector
Version Model NumberV6510E-23A
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100817489026618 [Unit of Use]
GS110817489026615 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HQAUnit, Cryotherapy, Ophthalmic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-05-07
Device Publish Date2017-12-17

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