Neuroguard IEP® System NG-0630-140-2

GUDID 00851616007583

The Neuroguard IEP System consists of three main components: • A self-expanding nitinol stent • A delivery catheter which includes a post-dilation balloon and activation handle • Embolic protection filter that is integrated at the distal end of the delivery system

Contego Medical, Inc.

Bare-metal carotid artery stent

• Primary Device ID: 00851616007583
• NIH Device Record Key: 997ee40b-23c2-44fa-8ea9-07f257d4cb2d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neuroguard IEP® System
• Version Model Number: NG-0630-140-2
• Catalog Number: NG-0630-140-2
• Company DUNS: 048268128
• Company Name: Contego Medical, 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: true
• 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: +1-800-708-7271
• Email: info@contegomedical.com
• Phone: +1-800-708-7271
• Email: info@contegomedical.com
• Phone: +1-800-708-7271
• Email: info@contegomedical.com
• Phone: +1-800-708-7271
• Email: info@contegomedical.com
• Phone: +1-800-708-7271
• Email: info@contegomedical.com
• Phone: +1-800-708-7271
• Email: info@contegomedical.com
• Phone: +1-800-708-7271
• Email: info@contegomedical.com
• Phone: +1-800-708-7271
• Email: info@contegomedical.com
• Phone: +1-800-708-7271
• Email: info@contegomedical.com
• Phone: +1-800-708-7271
• Email: info@contegomedical.com
• Phone: +1-800-708-7271
• Email: info@contegomedical.com
• Phone: +1-800-708-7271
• Email: info@contegomedical.com
• Phone: +1-800-708-7271
• Email: info@contegomedical.com
• Phone: +1-800-708-7271
• Email: info@contegomedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851616007583 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P240009

FDA Product Code

• NIM: Stent, Carotid

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: 2024-10-31
• Device Publish Date: 2024-10-23

On-Brand Devices [Neuroguard IEP® System]

• 00851616007613: The Neuroguard IEP System consists of three main components: • A self-expanding nitinol stent
• 00851616007606: The Neuroguard IEP System consists of three main components: • A self-expanding nitinol stent
• 00851616007590: The Neuroguard IEP System consists of three main components: • A self-expanding nitinol stent
• 00851616007583: The Neuroguard IEP System consists of three main components: • A self-expanding nitinol stent