Revolution 45MHz Rotational IVUS Imaging Catheter

GUDID 00184360000358

Volcarica S.R.L.

Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use
Primary Device ID00184360000358
NIH Device Record Key81b97793-1b96-4f43-a652-60d8b1026898
Commercial Distribution StatusIn Commercial Distribution
Brand NameRevolution 45MHz Rotational IVUS Imaging Catheter
Version Model Number89000
Company DUNS853202646
Company NameVolcarica S.R.L.
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 Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
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
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
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
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100184360000358 [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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-03-21
Device Publish Date2016-08-23

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00845225003050 - OmniWire Pressure Guide Wire, J-Tip2020-04-28 The OmniWire pressure guide wire is indicated for use to measure pressure in blood vessels, including both coronary and peripher
00845225002596 - Visions PV .035, 90 CM, US Digital IVUS Catheter2020-01-01
00845225001278 - Eagle Eye Platinum Digital IVUS Catheter2019-03-21
00845225002312 - Eagle Eye Platinum ST Digital IVUS Catheter2019-03-21
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