Tack Endovascular System (3.5-6.0mm) 156120061

GUDID 00863328000103

Sterile 6F System, 120cm

INTACT VASCULAR, INC.

Multiple peripheral artery stent, bare-metal

• Primary Device ID: 00863328000103
• NIH Device Record Key: eda2b4ea-2479-4acc-85c2-2705690ce16c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tack Endovascular System (3.5-6.0mm)
• Version Model Number: 6F
• Catalog Number: 156120061
• 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
• 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

• Device Size Text, specify: 0
• Catheter Working Length: 120 Centimeter
• Catheter Inner Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Working Length: 120 Centimeter
• Catheter Inner Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Working Length: 120 Centimeter
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• Device Size Text, specify: 0
• Catheter Working Length: 120 Centimeter
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• Catheter Working Length: 120 Centimeter
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• Device Size Text, specify: 0
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• Catheter Working Length: 120 Centimeter
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Working Length: 120 Centimeter
• Catheter Inner Diameter: 0.035 Inch
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• Catheter Working Length: 120 Centimeter
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Working Length: 120 Centimeter
• Catheter Inner Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Working Length: 120 Centimeter
• Catheter Inner Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Working Length: 120 Centimeter
• Catheter Inner Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Catheter Inner Diameter: 0.035 Inch
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• Catheter Working Length: 120 Centimeter
• Catheter Inner Diameter: 0.035 Inch
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• Catheter Inner Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Working Length: 120 Centimeter
• Catheter Inner Diameter: 0.035 Inch
• Device Size Text, specify: 0
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• Catheter Inner Diameter: 0.035 Inch
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• Catheter Working Length: 120 Centimeter
• Catheter Inner Diameter: 0.035 Inch
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• Catheter Working Length: 120 Centimeter
• Catheter Inner Diameter: 0.035 Inch
• Device Size Text, specify: 0
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• Catheter Inner Diameter: 0.035 Inch
• Device Size Text, specify: 0
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• Catheter Working Length: 120 Centimeter
• Catheter Inner Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Working Length: 120 Centimeter
• Catheter Inner Diameter: 0.035 Inch
• Device Size Text, specify: 0
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• Catheter Working Length: 120 Centimeter
• Catheter Inner Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Working Length: 120 Centimeter
• Catheter Inner Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Working Length: 120 Centimeter
• Catheter Inner Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Working Length: 120 Centimeter
• Catheter Inner Diameter: 0.035 Inch
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• Catheter Working Length: 120 Centimeter
• Catheter Inner Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Working Length: 120 Centimeter
• Catheter Inner Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Working Length: 120 Centimeter
• Catheter Inner Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Working Length: 120 Centimeter
• Catheter Inner Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Working Length: 120 Centimeter
• Catheter Inner Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Working Length: 120 Centimeter
• Catheter Inner Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Working Length: 120 Centimeter
• Catheter Inner Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Working Length: 120 Centimeter
• Catheter Inner Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Working Length: 120 Centimeter
• Catheter Inner Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Working Length: 120 Centimeter
• Catheter Inner Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Working Length: 120 Centimeter
• Catheter Inner Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Working Length: 120 Centimeter
• Catheter Inner Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Length: 120 Centimeter
• Catheter Length: 120 Centimeter
• Catheter Length: 120 Centimeter
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• Catheter Length: 120 Centimeter
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• Catheter Length: 120 Centimeter
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• Catheter Length: 120 Centimeter
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• Catheter Length: 120 Centimeter
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• Catheter Length: 120 Centimeter
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• Catheter Length: 120 Centimeter
• Catheter Length: 120 Centimeter
• Catheter Length: 120 Centimeter
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• Catheter Length: 120 Centimeter
• Catheter Length: 120 Centimeter
• Catheter Length: 120 Centimeter
• Catheter Length: 120 Centimeter
• Catheter Length: 120 Centimeter
• Catheter Length: 120 Centimeter
• Catheter Length: 120 Centimeter
• Catheter Length: 120 Centimeter
• Catheter Length: 120 Centimeter
• Catheter Length: 120 Centimeter
• Catheter Length: 120 Centimeter
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• Catheter Length: 120 Centimeter
• Catheter Length: 120 Centimeter
• Catheter Length: 120 Centimeter
• Catheter Length: 120 Centimeter
• Catheter Length: 120 Centimeter
• Catheter Length: 120 Centimeter
• Catheter Length: 120 Centimeter
• Catheter Length: 120 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
• 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	00863328000103 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P180034

FDA Product Code

• QCT: Scaffold, Dissection Repair

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-24
• Device Publish Date: 2019-04-30

On-Brand Devices [Tack Endovascular System (3.5-6.0mm)]

• 00863328000103: Sterile 6F System, 120cm
• 00863328000127: Sterile 6F System, 135cm
• 00863328000110: Sterile 6F System, 80cm