ClarifEye 002120

GUDID 00884838104570

Software medical device. Intended for use by professional healthcare providers as an intra-operative image-guidance tool used during surgical and interventional therapy.

Philips Medical Systems Nederland B.V.

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Primary Device ID00884838104570
NIH Device Record Key44bd25c7-1f5f-48b9-b9cb-85db88f9a115
Commercial Distribution StatusIn Commercial Distribution
Brand NameClarifEye
Version Model NumberClarifEye - 1
Catalog Number002120
Company DUNS413819707
Company NamePhilips Medical Systems Nederland B.V.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100884838104570 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OWBInterventional Fluoroscopic X-Ray System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-22
Device Publish Date2021-03-12

Devices Manufactured by Philips Medical Systems Nederland B.V.

00884838123809 - IntelliSpace Radiology 2024-04-12 IntelliSpace Radiology is a software package intended to be used by trained professionals, including but not limited to physicia
00884838111110 - LumiGuide2024-04-01 Angiographic guidewire with FORS technology, intended to direct a catheter during navigation in endovascular procedures of the p
00884838111127 - LumiGuide2024-04-01 Angiographic guidewire with FORS technology, intended to direct a catheter during navigation in endovascular procedures of the p
10884838111148 - LumiGuide2024-04-01 The LumiGuide 3D Hub enables the visualization of a connected endovascular catheter, when used in combination with a LumiGuide W
00884838117785 - Dunlee2024-02-08 1.5T 8CH T/R Knee Coil
00884838117761 - Dunlee2024-02-02 1.5 T/R Quad Extremity Coil
00884838099203 - Azurion2023-09-26 Monoplane Interventional X-Ray System. A floor-mounted monoplane system with a 12-inch flat detector.
00884838099210 - Azurion2023-09-26 Monoplane Interventional X-Ray System. A floor-mounted monoplane system with a 15-inch flat detector.

Trademark Results [ClarifEye]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CLARIFEYE
CLARIFEYE
90289466 not registered Live/Pending
Kobayashi Pharmaceuticals Co., Ltd.
2020-10-30
CLARIFEYE
CLARIFEYE
87446179 not registered Live/Pending
Kobayashi Pharmaceuticals Co., Ltd.
2017-05-11
CLARIFEYE
CLARIFEYE
79232424 not registered Live/Pending
Koninklijke Philips N.V.
2018-04-08
CLARIFEYE
CLARIFEYE
78675429 3120103 Dead/Cancelled
Antioch Company, The
2005-07-21

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