Ciliprobe Transsceral Cyclophotocoagulation Probe

GUDID 10817489025168

Quantel connector

KATALYST SURGICAL LLC

Ophthalmic fibreoptic light instrument, single-use
Primary Device ID10817489025168
NIH Device Record Keyf55dc4f7-3242-4853-80dd-dd5d606b0dc1
Commercial Distribution StatusIn Commercial Distribution
Brand NameCiliprobe Transsceral Cyclophotocoagulation Probe
Version Model NumberD4700C
Company DUNS007883297
Company NameKATALYST SURGICAL LLC
Device Count5
DM Exempttrue
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
GS100081748902516 [Unit of Use]
GS110817489025168 [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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-05-07
Device Publish Date2017-07-21

On-Brand Devices [Ciliprobe Transsceral Cyclophotocoagulation Probe]

10817489025168Quantel connector
10817489025151D4700A

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