PrimeWire Prestige Pressure Guide Wire 300cm JTIP

GUDID 00845225001179

Volcarica S.R.L.

Catheter-tip transducer, pressure Catheter-tip transducer, pressure Catheter-tip transducer, pressure Catheter-tip transducer, pressure Catheter-tip transducer, pressure Catheter-tip transducer, pressure Catheter-tip transducer, pressure Catheter-tip transducer, pressure Catheter-tip transducer, pressure Catheter-tip transducer, pressure Catheter-tip transducer, pressure Catheter-tip transducer, pressure Catheter-tip transducer, pressure Catheter-tip transducer, pressure Catheter-tip transducer, pressure Catheter-tip transducer, pressure Catheter-tip transducer, pressure

• Primary Device ID: 00845225001179
• NIH Device Record Key: e3972a4a-24a0-4f63-9721-9036b2ae5e2e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PrimeWire Prestige Pressure Guide Wire 300cm JTIP
• Version Model Number: 8300J
• 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	00845225001179 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100930

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: 2016-08-23

Devices Manufactured by Volcarica S.R.L.

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• 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
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• 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