Cili Probes (Cyclophotocoagulation)

GUDID 00840096211368

KATALYST SURGICAL LLC

Ophthalmic laser system beam guide
Primary Device ID00840096211368
NIH Device Record Key0b1e06a3-7e78-4331-9ed6-b561ba96e0de
Commercial Distribution StatusIn Commercial Distribution
Brand NameCili Probes (Cyclophotocoagulation)
Version Model Number620231
Company DUNS007883297
Company NameKATALYST SURGICAL LLC
Device Count5
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
GS100840096211368 [Unit of Use]
GS110840096211365 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LQJLens, Surgical, Laser, Accesssory, Ophthalmic Laser

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-12
Device Publish Date2020-03-04

Devices Manufactured by KATALYST SURGICAL LLC

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