ProxiCor for Pericardial Closure

GUDID 00859389005003

ProxiCor for Pericardial Closure is a decellularized natural scaffold for repairing the pericardium following cardiac surgery.

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: 00859389005003
• NIH Device Record Key: d4008770-be7b-4af7-b81a-30f81b973024
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProxiCor for Pericardial Closure
• Version Model Number: CMCV-059-401
• 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: 10 Centimeter
• Width: 7 Centimeter
• Height: 10 Centimeter
• Width: 7 Centimeter
• Height: 10 Centimeter
• Width: 7 Centimeter
• Height: 10 Centimeter
• Width: 7 Centimeter
• Height: 10 Centimeter
• Width: 7 Centimeter
• Height: 10 Centimeter
• Width: 7 Centimeter
• Height: 10 Centimeter
• Width: 7 Centimeter
• Height: 10 Centimeter
• Width: 7 Centimeter
• Height: 10 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	00859389005003 [Primary]
GS1	10859389005000 [Package]; Package: Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051405

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-03-01
• Device Publish Date: 2015-04-29

On-Brand Devices [ProxiCor for Pericardial Closure]

• 10859389005017: ProxiCor for Pericardial Closure is a decellularized natural scaffold for repairing the pericard
• 00859389005003: ProxiCor for Pericardial Closure is a decellularized natural scaffold for repairing the pericard