CONDUIT HC150
Hancock™ - HC150-25
Device Description
A xenograft (e.g., porcine or bovine heart valve) intended to be implanted in a patient during open heart surgery to repair/replace a dysfunctional pulmonary heart valve, or to replace a pulmonary valve in patients undergoing a pulmonary autograft (Ross) procedure. It is processed to render the tissue in the valve non-viable; it may be tissue only, or tissue attached to a metal or synthetic polymer framework. The device is typically used to treat acquired or congenital valvular disease.
Environmental Conditions
- Room temp storage up to 25°C (77°F) is satisfactory provided the conduit is not exposed to sunlight or other ultraviolet light sources or placed where significant temp fluctuations may occur
- 25.00
- 5.00
Device Sizes
- 25 MM
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: LWR
Device Name: Heart-Valve, Non-Allograft Tissue
Device Class: 3
Physical State: N/A
Definition: N/A
Submission Type ID: 2
Review Panel: CV
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: Y
Target Area: N/A
Regulation Number: N/A
Third Party Flag: N
Medical Specialty: N/A
Device IdentifiersDevice Id: 00763000517847
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A