PrimeWire Prestige Plus Pressure Guide Wire 185cm JTIP

GUDID 00845225001117

Volcarica S.R.L.

Catheter-tip transducer, pressure

• Primary Device ID: 00845225001117
• NIH Device Record Key: 88971d4b-7875-4efb-8e9d-65bf6a740f09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PrimeWire Prestige Plus Pressure Guide Wire 185cm JTIP
• Version Model Number: 9185J
• Company DUNS: 853202646
• Company Name: Volcarica S.R.L.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00845225001117 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111395

FDA Product Code

• DQX: Wire, Guide, Catheter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-22

Devices Manufactured by Volcarica S.R.L.

• 00845225003029 - VeriSight (2D) ICE Catheter: 2020-09-23 The VeriSight/VeriSight Pro ICE Catheter is intended for intracardiac and intra-luminal visualization of cardiac and great vesse
• 00845225003036 - VeriSight Pro (3D) ICE Catheter: 2020-09-23 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 Tip: 2020-04-28 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-Tip: 2020-04-28 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 Catheter: 2020-01-01
• 00845225001278 - Eagle Eye Platinum Digital IVUS Catheter: 2019-03-21
• 00845225002312 - Eagle Eye Platinum ST Digital IVUS Catheter: 2019-03-21
• 00845225002329 - Visions PV .035 Digital IVUS Catheter: 2019-03-21