Tyke, Patch, Pledget and Intracardiac

GUDID 10859389005109

Tyke is intended for use in neonates and infants for repair of pericardial structures, as an epicardial covering for damaged or repaired cardiac structures, as a patch material for intracardiac defects, septal defect and annulus repair, suture-line buttressing, and cardiac repair.

AZIYO BIOLOGICS, INC.

Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived

• Primary Device ID: 10859389005109
• NIH Device Record Key: c8709cb5-e244-44be-8415-8acfa66ba448
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tyke, Patch, Pledget and Intracardiac
• Version Model Number: CMCV-098-204
• Company DUNS: 080251450
• Company Name: AZIYO BIOLOGICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 470-514-4080
• Email: xxx@xx.xx
• Phone: 470-514-4080
• Email: xxx@xx.xx
• Phone: 470-514-4080
• Email: xxx@xx.xx
• Phone: 470-514-4080
• Email: xxx@xx.xx
• Phone: 470-514-4080
• Email: xxx@xx.xx
• Phone: 470-514-4080
• Email: xxx@xx.xx
• Phone: 470-514-4080
• Email: xxx@xx.xx
• Phone: 470-514-4080
• Email: xxx@xx.xx
• Phone: 470-514-4080
• Email: xxx@xx.xx
• Phone: 470-514-4080
• Email: xxx@xx.xx
• Phone: 470-514-4080
• Email: xxx@xx.xx
• Phone: 470-514-4080
• Email: xxx@xx.xx

Device Dimensions

• Width: 7 Centimeter
• Width: 7 Centimeter
• Height: 4 Centimeter
• Width: 7 Centimeter
• Height: 4 Centimeter
• Width: 7 Centimeter
• Height: 4 Centimeter
• Width: 7 Centimeter
• Height: 4 Centimeter
• Width: 7 Centimeter
• Height: 4 Centimeter
• Width: 7 Centimeter
• Height: 4 Centimeter
• Width: 7 Centimeter
• Height: 4 Centimeter
• Width: 7 Centimeter
• Height: 4 Centimeter
• Width: 7 Centimeter
• Height: 4 Centimeter
• Width: 7 Centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859389005102 [Primary]
GS1	10859389005109 [Package]; Contains: 00859389005102; Package: Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152127

FDA Product Code

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

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: 2019-03-11
• Device Publish Date: 2019-02-28

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• 04035479160548 - Biotronik BioEnvelope: 2021-02-05 The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implant
• 04035479160647 - Biotronik BioEnvelope: 2021-02-05 The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implant
• 10859389005109 - Tyke, Patch, Pledget and Intracardiac: 2019-03-11Tyke is intended for use in neonates and infants for repair of pericardial structures, as an epicardial covering for damaged or repaired cardiac structures, as a patch material for intracardiac defects, septal defect and annulus repair, suture-line buttressing, and cardiac repair.
• 10859389005109 - Tyke, Patch, Pledget and Intracardiac: 2019-03-11 Tyke is intended for use in neonates and infants for repair of pericardial structures, as an epicardial covering for damaged or
• 10859389005116 - CanGaroo Envelope: 2019-03-11 The CanGaroo® Envelope is intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator t
• 10859389005024 - CanGaroo Envelope: 2019-03-06 The CanGaroo® Envelope is intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator t