ICE PIM

GUDID 00845225012854

Philips Image Guided Therapy Corporation

Intravascular ultrasound imaging catheter, single-use
Primary Device ID00845225012854
NIH Device Record Keyb77c9e21-9e61-4593-8ba9-f1223b4630d5
Commercial Distribution StatusIn Commercial Distribution
Brand NameICE PIM
Version Model NumberVSICEPIM
Company DUNS018860556
Company NamePhilips Image Guided Therapy Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100845225012854 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OBJCatheter, Ultrasound, Intravascular

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-28
Device Publish Date2021-07-20

Devices Manufactured by Philips Image Guided Therapy Corporation

00845225003425 - Pioneer Plus Catheter2024-08-20
20813132029412 - Quick-Cross Extreme2023-10-12 Quick-Cross Extreme Support Catheter
20813132029429 - Quick-Cross Extreme2023-10-12 Quick-Cross Extreme Support Catheter
20813132029436 - Quick-Cross Extreme2023-10-12 Quick-Cross Extreme Support Catheter
20813132029443 - Quick-Cross Extreme2023-10-12 Quick-Cross Extreme Support Catheter
20813132029450 - Quick-Cross Extreme2023-10-12 Quick-Cross Extreme Support Catheter
00813132029463 - Quick-Cross Extreme2023-10-12 Quick-Cross Extreme Support Catheter
20813132029474 - Quick-Cross Extreme2023-10-12 Quick-Cross Extreme Support Catheter

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