Visions PV .035, 90 CM, US Digital IVUS Catheter

GUDID 00845225002598

Volcarica S.R.L.

Intravascular ultrasound imaging catheter, single-use

• Primary Device ID: 00845225002598
• NIH Device Record Key: 0c58c87c-e689-4b49-8d3e-a43e4467cd10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Visions PV .035, 90 CM, US Digital IVUS Catheter
• Version Model Number: 81234
• 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	00845225002598 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121273

FDA Product Code

• OBJ: Catheter, Ultrasound, Intravascular

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: 2019-03-21
• Device Publish Date: 2016-08-23

On-Brand Devices [Visions PV .035, 90 CM, US Digital IVUS Catheter]

• 00845225002598: 81234
• 00845225002596: 81234