Sundt™

GUDID M269NL85050761

Sundt™ External Carotid Endarterectomy Shunt is designed to allow formation of an external loop and used to provide temporary carotid bypass for cerebral circulation during carotid endartectomy procedures.

Integra Lifesciences Corporation

Carotid artery shunt

• Primary Device ID: M269NL85050761
• NIH Device Record Key: 4798caa7-e3bb-48f2-9d38-16082b1bad77
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sundt™
• Version Model Number: NL8505076
• Company DUNS: 083171244
• Company Name: Integra Lifesciences Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780026280 [Primary]
HIBCC	M269NL85050761 [Secondary]

FDA Product Code

• DWF: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-09-22
• Device Publish Date: 2016-06-20

On-Brand Devices [Sundt™]

• 10381780072508: One external carotid endarectomy shunt, 30cm non-reinforced segment and a 12cm venting arm with
• 10381780072188: SUNDT EXT. CAROTID ENDARTER SHU. The Integra Sundt external carotid endartecrectomy shunt is des
• M269NL85050791: Sundt™ External Carotid Endarterectomy Shunt is designed to allow formation of an external loo
• M269NL85050631: Sundt™ Internal Carotid Endarterectomy Shunt is designed for placement within the artery and
• M269NL85050621: Sundt™ Internal Carotid Endarterectomy Shunt is designed for placement within the artery and
• M269NL85050611: Sundt™ Internal Carotid Endarterectomy Shunt is designed for placement within the artery and
• M269NL85050601: Sundt™ Internal Carotid Endarterectomy Shunt is designed for placement within the artery and
• M269NL85050781: Sundt™ External Carotid Endarterectomy Shunt is designed to allow formation of an external loo
• M269NL85050771: Sundt™ External Carotid Endarterectomy Shunt is designed to allow formation of an external loo
• M269NL85050761: Sundt™ External Carotid Endarterectomy Shunt is designed to allow formation of an external loo
• M269NL85050721: Sundt™ External Carotid Endarterectomy Shunt is designed to allow formation of an external loo
• M269NL85050711: Sundt™ External Carotid Endarterectomy Shunt is designed to allow formation of an external loo
• M269NL85050701: Sundt™ External Carotid Endarterectomy Shunt is designed to allow formation of an external loo
• M269NL85050671: Sundt™ Internal Carotid Endarterectomy Shunt is designed for placement within the artery and
• M269NL85050661: Sundt™ Internal Carotid Endarterectomy Shunt is designed for placement within the artery and
• M269NL85050651: Sundt™ Internal Carotid Endarterectomy Shunt is designed for placement within the artery and