ENROUTE Transcarotid Stent SR-080630-TCS

GUDID 00811311021260

8-6mm x 30mm

SILK ROAD MEDICAL, INC.

Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent

• Primary Device ID: 00811311021260
• NIH Device Record Key: 60de2826-a0c6-474b-a4b6-295a0fce74ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENROUTE Transcarotid Stent
• Version Model Number: FG11815
• Catalog Number: SR-080630-TCS
• Company DUNS: 022516829
• Company Name: SILK ROAD 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: 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
• 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	00811311021260 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P140026

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: 2023-06-30
• Device Publish Date: 2023-06-22

On-Brand Devices [ENROUTE Transcarotid Stent]

• 00811311020539: 10 mm X 40 mm
• 00811311020522: 10 mm X 30 mm
• 00811311020515: 10 mm X 20 mm
• 00811311020508: 9 mm X 40 mm
• 00811311020492: 9 mm X 30 mm
• 00811311020485: 9 mm X 20 mm
• 00811311020478: 8 mm X 40 mm
• 00811311020461: 8 mm X 30 mm
• 00811311020454: 8 mm X 20 mm
• 00811311020447: 7 mm X 40 mm
• 00811311020430: 7 mm X 30 mm
• 00811311020423: 7 mm X 20 mm
• 00811311020416: 6 mm X 40 mm
• 00811311020409: 6 mm X 30 mm
• 00811311020393: 6 mm X 20 mm
• 00811311020386: 5 mm X 40 mm
• 00811311020379: 5 mm X 30 mm
• 00811311020362: 5 mm X 20 mm
• 00811311021321: 10-7mm x 40mm
• 00811311021314: 10-8mm x 40mm
• 00811311021307: 10-8mm x 30mm
• 00811311021291: 9-7mm x 40mm
• 00811311021284: 9-7mm x 30mm
• 00811311021277: 8-6mm x 40mm
• 00811311021260: 8-6mm x 30mm