EmboGuide 001012

GUDID 00884838059290

Software medical device, used with a Philips Interventional X-Ray System. Extension of XperCT. Assists physicians with embolization of hypervascular tumors in the liver using interventional X-ray.

Philips Medical Systems Nederland B.V.

Angiographic x-ray system application software
Primary Device ID00884838059290
NIH Device Record Key44266bac-0a37-4063-98cc-f09541db7143
Commercial Distribution StatusIn Commercial Distribution
Brand NameEmboGuide
Version Model NumberEmboGuide R1
Catalog Number001012
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
GS100884838059290 [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 StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-10-24
Device Publish Date2016-09-24

Devices Manufactured by Philips Medical Systems Nederland B.V.

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00884838118485 - Philips2024-07-26 MRI Needle Block 12G
00884838118492 - Philips2024-07-26 MRI Needle Block 14G
00884838118508 - Philips2024-07-26 MRI Needle Block 16G
00884838118515 - Philips2024-07-26 MRI Needle Block 18G
00884838118522 - Philips2024-07-26 MRI Needle Sleeve 12G

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