ProxiCor for Cardiac Tissue Repair

GUDID 10859389005055

ProxiCor for Cardiac Tissue Repair is indicated for use as an intracardiac patch or pledget for tissue repair and suture-line buttressing.

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: 10859389005055
• NIH Device Record Key: 95e52f4c-7ea0-49cf-997f-b94271e5ff79
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProxiCor for Cardiac Tissue Repair
• Version Model Number: CMCV-067-404
• 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

• Height: 4 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
• Height: 4 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	00859389005058 [Primary]
GS1	10859389005055 [Package]; Contains: 00859389005058; Package: Box [5 Units]; Discontinued: 2018-12-31; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063349

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: 5
• Public Version Date: 2019-03-01
• Device Publish Date: 2015-07-01

On-Brand Devices [ProxiCor for Cardiac Tissue Repair]

• 10859389005055: ProxiCor for Cardiac Tissue Repair is indicated for use as an intracardiac patch or pledget for
• 10859389005048: ProxiCor for Cardiac Tissue Repair is indicated for use as an intracardiac patch or pledget for