Primary Device ID | 00845225003371 |
NIH Device Record Key | e2d123f8-4281-41d9-aaa6-50b0ecb8dc6b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Eagle Eye Platinum ST RX Digital IVUS Catheter |
Version Model Number | 85900PST |
Catalog Number | 85900PST |
Company DUNS | 118354223 |
Company Name | Philips Image Guided Therapy Corporation |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Unsafe |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | true |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | (800) 228-4728 |
IGTD.CustomerInquiry@philips.com | |
Phone | (800) 228-4728 |
IGTD.CustomerInquiry@philips.com | |
Phone | (800) 228-4728 |
IGTD.CustomerInquiry@philips.com | |
Phone | (800) 228-4728 |
IGTD.CustomerInquiry@philips.com | |
Phone | (800) 228-4728 |
IGTD.CustomerInquiry@philips.com |
Length | 150 Centimeter |
Device Size Text, specify | 0 |
Length | 150 Centimeter |
Device Size Text, specify | 0 |
Length | 150 Centimeter |
Device Size Text, specify | 0 |
Length | 150 Centimeter |
Device Size Text, specify | 0 |
Storage Environment Temperature | Between -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Storage Environment Temperature | Between -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Storage Environment Temperature | Between -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Storage Environment Temperature | Between -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00845225003371 [Primary] |
OBJ | Catheter, Ultrasound, Intravascular |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-10-02 |
Device Publish Date | 2025-09-24 |
00845225003319 - Visions PV .014P RX Digital IVUS Catheter | 2025-10-02 Visions PV .014P rapid exchange digital intravascular ultrasound catheter |
00845225003364 - Eagle Eye Platinum RX Digital IVUS Catheter | 2025-10-02 Eagle Eye Platinum rapid exchange digital intravascular ultrasound catheter |
00845225003371 - Eagle Eye Platinum ST RX Digital IVUS Catheter | 2025-10-02Eagle Eye Platinum short tip rapid exchange digital intravascular ultrasound catheter |
00845225003371 - Eagle Eye Platinum ST RX Digital IVUS Catheter | 2025-10-02 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 Catheter | 2024-08-20 |
20813132029412 - Quick-Cross Extreme | 2023-10-12 Quick-Cross Extreme Support Catheter |
20813132029429 - Quick-Cross Extreme | 2023-10-12 Quick-Cross Extreme Support Catheter |
20813132029436 - Quick-Cross Extreme | 2023-10-12 Quick-Cross Extreme Support Catheter |