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

• 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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• 00877234000119 - CardioGenesis: 2018-07-06 Pearl 5.0 Handpiece Delivery System
• 10877234000154 - BioGlue Surgical Adhesive: 2018-07-06 BioGlue Surgical Adhesive Applicator Tips
• 00877234000164 - BioGlue Surgical Adhesive: 2018-07-06 BioGlue Surgical Adhesive Syringe Extender Tips