ENROUTE Enflate Transcarotid RX Balloon Dilation Catheter SR-4025-BC

GUDID 00811311020928

4mm x 25mm

SILK ROAD MEDICAL, INC.

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• Primary Device ID: 00811311020928
• NIH Device Record Key: 28de6720-c13d-49e8-b82b-2e3f460857ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENROUTE Enflate Transcarotid RX Balloon Dilation Catheter
• Version Model Number: SR-4025-BC
• Catalog Number: SR-4025-BC
• 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: customerservicce@silkroadmed.com
• Phone: 1-855-410-8227
• Email: customerservicce@silkroadmed.com
• Phone: 1-855-410-8227
• Email: customerservicce@silkroadmed.com
• Phone: 1-855-410-8227
• Email: customerservicce@silkroadmed.com
• Phone: 1-855-410-8227
• Email: customerservicce@silkroadmed.com
• Phone: 1-855-410-8227
• Email: customerservicce@silkroadmed.com
• Phone: 1-855-410-8227
• Email: customerservicce@silkroadmed.com
• Phone: 1-855-410-8227
• Email: customerservicce@silkroadmed.com
• Phone: 1-855-410-8227
• Email: customerservicce@silkroadmed.com
• Phone: 1-855-410-8227
• Email: customerservicce@silkroadmed.com
• Phone: 1-855-410-8227
• Email: customerservicce@silkroadmed.com
• Phone: 1-855-410-8227
• Email: customerservicce@silkroadmed.com
• Phone: 1-855-410-8227
• Email: customerservicce@silkroadmed.com
• Phone: 1-855-410-8227
• Email: customerservicce@silkroadmed.com
• Phone: 1-855-410-8227
• Email: customerservicce@silkroadmed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811311020928 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221414

FDA Product Code

• LIT: Catheter, Angioplasty, Peripheral, Transluminal

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: 2022-11-03
• Device Publish Date: 2022-10-26

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