Verrata Pressure Guide Wire 300cm

GUDID 00845225002459

Volcarica S.R.L.

Catheter-tip transducer, pressure
Primary Device ID00845225002459
NIH Device Record Key1bbb2235-c631-4828-aeee-399784e981d1
Commercial Distribution StatusIn Commercial Distribution
Brand NameVerrata Pressure Guide Wire 300cm
Version Model Number10300
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100845225002459 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXOTransducer, Pressure, Catheter Tip

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2016-08-22

Devices Manufactured by Volcarica S.R.L.

00845225003029 - VeriSight (2D) ICE Catheter2020-09-23 The VeriSight/VeriSight Pro ICE Catheter is intended for intracardiac and intra-luminal visualization of cardiac and great vesse
00845225003036 - VeriSight Pro (3D) ICE Catheter2020-09-23 The VeriSight/VeriSight Pro ICE Catheter is intended for intracardiac and intra-luminal visualization of cardiac and great vesse
00845225003043 - OmniWire Pressure Guide Wire, Straight Tip2020-04-28 The OmniWire pressure guide wire is indicated for use to measure pressure in blood vessels, including both coronary and peripher
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
00845225002329 - Visions PV .035 Digital IVUS Catheter2019-03-21

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.