CryoPatch SG Pulmonary Hemi
CryoPatch® SG Pulmonary Human Cardiac Hemi-Artery Patch - SGPH00
Device Description
An implantable heart tissue allograft obtained from a human cadaver intended to be implanted in the heart during open heart surgery, to be used for repair or reconstruction of a dysfunctional right ventricular outflow tract. It is aseptically processed, and treated to render the tissue decellularized. It may be supplied in various configurations including pulmonary hemi-artery, pulmonary trunk and pulmonary branch.
Environmental Conditions
- At or Below -135 degrees Celsius
Device Sizes
- Branch Length: 1.0cm (minimum) (allograft specific)
- Proximal Base: 30mm (minimum) (allograft specific)
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: DXZ
Device Name: Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
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: 870.3470
Third Party Flag: N
Medical Specialty: CV
Device IdentifiersDevice Id: 00877234000461
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
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