Tru-Incise Valvulotome with Interchangeable Heads TIVH20

GUDID H862TIVH20NC2

Tru-Incise 2mm Cutting Head

URESIL, LLC

Valvulotome, percutaneous Valvulotome, percutaneous Valvulotome, percutaneous Valvulotome, percutaneous Valvulotome, percutaneous Valvulotome, percutaneous Valvulotome, percutaneous Valvulotome, percutaneous Valvulotome, percutaneous Valvulotome, percutaneous Valvulotome, percutaneous Valvulotome, percutaneous Valvulotome, percutaneous Valvulotome, percutaneous Valvulotome, percutaneous Valvulotome, percutaneous

• Primary Device ID: H862TIVH20NC2
• NIH Device Record Key: 28ab2a33-d618-4d61-9af4-3a402f8531fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tru-Incise Valvulotome with Interchangeable Heads
• Version Model Number: TIVH20
• Catalog Number: TIVH20
• Company DUNS: 192559557
• Company Name: URESIL, LLC
• 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: true
• Serial Number: false
• 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

Customer Support Contacts

• Phone: 1-800-538-7374
• Email: sales@uresil.com
• Phone: 1-800-538-7374
• Email: sales@uresil.com
• Phone: 1-800-538-7374
• Email: sales@uresil.com
• Phone: 1-800-538-7374
• Email: sales@uresil.com
• Phone: 1-800-538-7374
• Email: sales@uresil.com
• Phone: 1-800-538-7374
• Email: sales@uresil.com
• Phone: 1-800-538-7374
• Email: sales@uresil.com
• Phone: 1-800-538-7374
• Email: sales@uresil.com
• Phone: 1-800-538-7374
• Email: sales@uresil.com
• Phone: 1-800-538-7374
• Email: sales@uresil.com
• Phone: 1-800-538-7374
• Email: sales@uresil.com
• Phone: 1-800-538-7374
• Email: sales@uresil.com
• Phone: 1-800-538-7374
• Email: sales@uresil.com
• Phone: 1-800-538-7374
• Email: sales@uresil.com
• Phone: 1-800-538-7374
• Email: sales@uresil.com
• Phone: 1-800-538-7374
• Email: sales@uresil.com

Device Dimensions

• Outer Diameter: 2 Micrometer
• Outer Diameter: 2 Micrometer
• Outer Diameter: 2 Micrometer
• Outer Diameter: 2 Micrometer
• Outer Diameter: 2 Micrometer
• Outer Diameter: 2 Micrometer
• Outer Diameter: 2 Micrometer
• Outer Diameter: 2 Micrometer
• Outer Diameter: 2 Micrometer
• Outer Diameter: 2 Micrometer
• Outer Diameter: 2 Micrometer
• Outer Diameter: 2 Micrometer
• Outer Diameter: 2 Micrometer
• Outer Diameter: 2 Micrometer
• Outer Diameter: 2 Micrometer
• Outer Diameter: 2 Micrometer

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H862TIVH20NC0 [Primary]
HIBCC	H862TIVH20NC1 [Package]; Contains: H862TIVH20NC0; Package: Dispenser [1 Units]; In Commercial Distribution
HIBCC	H862TIVH20NC2 [Package]; Contains: H862TIVH20NC1; Package: Shipper [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K930011

FDA Product Code

• MGZ: Valvulotome

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-25
• Device Publish Date: 2019-09-17

On-Brand Devices [Tru-Incise Valvulotome with Interchangeable Heads]

• H862TIVH302: Tru-Incise 3mm Cutting Head
• H862TIVH202: Tru-Incise 2mm Cutting Head
• H862TIVC2: Tru-Incise Valvulotome Catheter Kit
• H862TIVH40NC2: Tru-Incise 4mm Cutting Head
• H862TIVH30NC2: Tru-Incise 3mm Cutting Head
• H862TIVH20NC2: Tru-Incise 2mm Cutting Head
• H862TIVCNC2: Tru-Incise Valvulotome Catheter Kit
• H862TIVK2030NC2: Tru-Incise Valvulotome
• H862TIVK20302: Tru-Incise Valvulotome
• H862TIVH402: Tru-Incise 4mm Cutting Head