ENROUTE Transcarotid Neuroprotection System SR-250-NPS

GUDID 00811311021062

SILK ROAD MEDICAL, INC.

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• Primary Device ID: 00811311021062
• NIH Device Record Key: fe2302ab-a898-4864-b5cc-345ab4f8415e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENROUTE Transcarotid Neuroprotection System
• Version Model Number: FG12531
• Catalog Number: SR-250-NPS
• Company DUNS: 022516829
• Company Name: SILK ROAD MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-855-410-8227
• Email: customerservice@silkroadmed.com
• Phone: 1-855-410-8227
• Email: customerservice@silkroadmed.com
• Phone: 1-855-410-8227
• Email: customerservice@silkroadmed.com
• Phone: 1-855-410-8227
• Email: customerservice@silkroadmed.com
• Phone: 1-855-410-8227
• Email: customerservice@silkroadmed.com
• Phone: 1-855-410-8227
• Email: customerservice@silkroadmed.com
• Phone: 1-855-410-8227
• Email: customerservice@silkroadmed.com
• Phone: 1-855-410-8227
• Email: customerservice@silkroadmed.com
• Phone: 1-855-410-8227
• Email: customerservice@silkroadmed.com
• Phone: 1-855-410-8227
• Email: customerservice@silkroadmed.com
• Phone: 1-855-410-8227
• Email: customerservice@silkroadmed.com
• Phone: 1-855-410-8227
• Email: customerservice@silkroadmed.com
• Phone: 1-855-410-8227
• Email: customerservice@silkroadmed.com
• Phone: 1-855-410-8227
• Email: customerservice@silkroadmed.com
• Phone: 1-855-410-8227
• Email: customerservice@silkroadmed.com
• Phone: 1-855-410-8227
• Email: customerservice@silkroadmed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811311021062 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230402

FDA Product Code

• NTE: Temporary Carotid Catheter For Embolic Capture

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: 2023-05-02
• Device Publish Date: 2023-04-24

On-Brand Devices [ENROUTE Transcarotid Neuroprotection System]

• 00811311020829: Angled-Tip Arterial Sheath Configuration
• 00811311020775: Straight-Tip Arterial Sheath Configuration
• 00811311020744: Angled-Tip Arterial Sheath Configuration
• 00811311021062: FG12531