VasCure for Vascular Repair

GUDID 10859389005123

VasCure for Vascular Repair is intended for use as a patch material for repair and reconstruction of peripheral vasculature including the carotid, renal, iliac, femoral, and tibial blood vessels. VasCure for Vascular Repair may be used for patch closure of vessels, as a pledget, or for suture line buttressing when repairing peripheral vessels.

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: 10859389005123
• NIH Device Record Key: a7534e7a-60a7-44de-aa8a-12566c814bd8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VasCure for Vascular Repair
• Version Model Number: CMCV-011-606
• 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: 10 Centimeter
• Width: 10 Centimeter
• Height: 2 Centimeter
• Width: 10 Centimeter
• Height: 2 Centimeter
• Width: 10 Centimeter
• Height: 2 Centimeter
• Width: 10 Centimeter
• Height: 2 Centimeter
• Width: 10 Centimeter
• Height: 2 Centimeter
• Width: 10 Centimeter
• Height: 2 Centimeter
• Width: 10 Centimeter
• Height: 2 Centimeter
• Width: 10 Centimeter
• Height: 2 Centimeter
• Width: 10 Centimeter
• Height: 2 Centimeter
• Width: 10 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	00859389005126 [Primary]
GS1	10859389005123 [Package]; Contains: 00859389005126; Package: Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140789

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: 2015-07-01

On-Brand Devices [VasCure for Vascular Repair]

• 10859389005147: VasCure for Vascular Repair is intended for use as a patch material for repair and reconstructio
• 10859389005123: VasCure for Vascular Repair is intended for use as a patch material for repair and reconstructio