Eagle Eye Platinum RX Digital IVUS Catheter 85900P

GUDID 00845225003364

Eagle Eye Platinum rapid exchange digital intravascular ultrasound catheter

Philips Image Guided Therapy Corporation

Intravascular ultrasound imaging catheter, single-use
Primary Device ID00845225003364
NIH Device Record Key0eddf4ed-b498-4d39-9bd6-8194d4dcbd49
Commercial Distribution StatusIn Commercial Distribution
Brand NameEagle Eye Platinum RX Digital IVUS Catheter
Version Model Number85900P
Catalog Number85900P
Company DUNS118354223
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com

Device Dimensions

Length150 Centimeter
Device Size Text, specify0
Length150 Centimeter
Device Size Text, specify0
Length150 Centimeter
Device Size Text, specify0
Length150 Centimeter
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS100845225003364 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OBJCatheter, Ultrasound, Intravascular

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-10-02
Device Publish Date2025-09-24

Devices Manufactured by Philips Image Guided Therapy Corporation

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00845225003364 - Eagle Eye Platinum RX Digital IVUS Catheter2025-10-02Eagle Eye Platinum rapid exchange digital intravascular ultrasound catheter
00845225003364 - Eagle Eye Platinum RX Digital IVUS Catheter2025-10-02 Eagle Eye Platinum rapid exchange digital intravascular ultrasound catheter
00845225003371 - Eagle Eye Platinum ST RX Digital IVUS Catheter2025-10-02 Eagle Eye Platinum short tip rapid exchange digital intravascular ultrasound catheter
00845225012984 - Patient Interface Module (PIMr)2025-09-01 Patient interface module for rotational intravascular ultrasound catheters
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

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