CryoPatch® SG Pulmonary Human Cardiac Trunk Patch SGP010

GUDID 00877234000478

CryoPatch SG Pulmonary Trunk The CryoPatch SG Pulmonary Human Cardiac Patch is a human heart valve aseptically recovered from donated human tissue.

Cryolife, Inc.

Cadaveric pulmonary artery bioprosthesis Cadaveric pulmonary artery bioprosthesis Cadaveric pulmonary artery bioprosthesis Cadaveric pulmonary artery bioprosthesis Cadaveric pulmonary artery bioprosthesis Cadaveric pulmonary artery bioprosthesis Cadaveric pulmonary artery bioprosthesis Cadaveric pulmonary artery bioprosthesis Cadaveric pulmonary artery bioprosthesis Cadaveric pulmonary artery bioprosthesis Cadaveric pulmonary artery bioprosthesis Cadaveric pulmonary artery bioprosthesis Cadaveric pulmonary artery bioprosthesis Cadaveric pulmonary artery bioprosthesis Cadaveric pulmonary artery bioprosthesis Cadaveric pulmonary artery bioprosthesis Cadaveric pulmonary artery bioprosthesis Cadaveric pulmonary artery bioprosthesis Cadaveric pulmonary artery bioprosthesis

• Primary Device ID: 00877234000478
• NIH Device Record Key: 8b36a2c4-0ae9-4ef5-b2e7-7d57c34d9609
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CryoPatch® SG Pulmonary Human Cardiac Trunk Patch
• Version Model Number: SGP010
• Catalog Number: SGP010
• Company DUNS: 119253177
• Company Name: Cryolife, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: true
• 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: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 770-419-3355
• Email: xxx@xx.xx
• Phone: 770-419-3355
• Email: xxx@xx.xx
• Phone: 770-419-3355
• Email: xxx@xx.xx
• Phone: 770-419-3355
• Email: xxx@xx.xx
• Phone: 770-419-3355
• Email: xxx@xx.xx
• Phone: 770-419-3355
• Email: xxx@xx.xx
• Phone: 770-419-3355
• Email: xxx@xx.xx
• Phone: 770-419-3355
• Email: xxx@xx.xx
• Phone: 770-419-3355
• Email: xxx@xx.xx
• Phone: 770-419-3355
• Email: xxx@xx.xx
• Phone: 770-419-3355
• Email: xxx@xx.xx
• Phone: 770-419-3355
• Email: xxx@xx.xx
• Phone: 770-419-3355
• Email: xxx@xx.xx
• Phone: 770-419-3355
• Email: xxx@xx.xx
• Phone: 770-419-3355
• Email: xxx@xx.xx
• Phone: 770-419-3355
• Email: xxx@xx.xx
• Phone: 770-419-3355
• Email: xxx@xx.xx
• Phone: 770-419-3355
• Email: xxx@xx.xx
• Phone: 770-419-3355
• Email: xxx@xx.xx
• Phone: 770-419-3355
• Email: xxx@xx.xx

Device Dimensions

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Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *At or Below -135 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *At or Below -135 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *At or Below -135 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *At or Below -135 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *At or Below -135 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *At or Below -135 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *At or Below -135 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *At or Below -135 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *At or Below -135 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *At or Below -135 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *At or Below -135 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *At or Below -135 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *At or Below -135 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *At or Below -135 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *At or Below -135 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *At or Below -135 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *At or Below -135 degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00877234000478 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101866

FDA Product Code

• DXZ: Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-11

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• 00877234000454 - CryoValve® SG Pulmonary Human Heart Valve: 2018-07-24 Pulmonary Valve SG The CryoValve SG Pulmonary Human Heart Valve is a human heart valve aseptically recovered from donated human
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