Tack Endovascular System (1.5-4.5mm) 154090041

GUDID 00863328000189

Sterile 4F System, 90cm

INTACT VASCULAR, INC.

Multiple peripheral artery stent, bare-metal Multiple peripheral artery stent, bare-metal Multiple peripheral artery stent, bare-metal Multiple peripheral artery stent, bare-metal Multiple peripheral artery stent, bare-metal Multiple peripheral artery stent, bare-metal Multiple peripheral artery stent, bare-metal Multiple peripheral artery stent, bare-metal Multiple peripheral artery stent, bare-metal Multiple peripheral artery stent, bare-metal Multiple peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal

• Primary Device ID: 00863328000189
• NIH Device Record Key: 1c1297e0-ac83-4cb8-9aa4-dc3d9e246e93
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tack Endovascular System (1.5-4.5mm)
• Version Model Number: 4F
• Catalog Number: 154090041
• Company DUNS: 078732453
• Company Name: INTACT VASCULAR, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com
• Phone: 800-865-0214
• Email: cs@intactvascular.com

Device Dimensions

• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Inner Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Inner Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Inner Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Inner Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Inner Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Inner Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Inner Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Inner Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Inner Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Inner Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Inner Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Inner Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Inner Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Inner Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Inner Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Inner Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Inner Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Inner Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Inner Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Inner Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Inner Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Inner Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Inner Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Inner Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Inner Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Inner Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Inner Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Inner Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Inner Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Inner Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Inner Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Inner Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Inner Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Inner Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Inner Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Inner Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Inner Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Inner Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Inner Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Inner Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Inner Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Inner Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Inner Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Inner Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Inner Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Catheter Length: 90 Centimeter
• Catheter Length: 90 Centimeter
• Catheter Length: 90 Centimeter
• Catheter Length: 90 Centimeter
• Catheter Length: 90 Centimeter
• Catheter Length: 90 Centimeter
• Catheter Length: 90 Centimeter
• Catheter Length: 90 Centimeter
• Catheter Length: 90 Centimeter
• Catheter Length: 90 Centimeter
• Catheter Length: 90 Centimeter
• Catheter Length: 90 Centimeter
• Catheter Length: 90 Centimeter
• Catheter Length: 90 Centimeter
• Catheter Length: 90 Centimeter
• Catheter Length: 90 Centimeter
• Catheter Length: 90 Centimeter
• Catheter Length: 90 Centimeter
• Catheter Length: 90 Centimeter
• Catheter Length: 90 Centimeter
• Catheter Length: 90 Centimeter
• Catheter Length: 90 Centimeter
• Catheter Length: 90 Centimeter
• Catheter Length: 90 Centimeter
• Catheter Length: 90 Centimeter
• Catheter Length: 90 Centimeter
• Catheter Length: 90 Centimeter
• Catheter Length: 90 Centimeter
• Catheter Length: 90 Centimeter
• Catheter Length: 90 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00863328000189 [Primary]

FDA Product Code

• QCT: Scaffold, Dissection Repair

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: 2020-04-21
• Device Publish Date: 2020-04-13

On-Brand Devices [Tack Endovascular System (1.5-4.5mm)]

• 00863328000196: Sterile 4F System, 150cm
• 00863328000189: Sterile 4F System, 90cm