ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter SR-4535-BC

GUDID 00811311021000

4.5mm X 35mm

SILK ROAD MEDICAL, INC.

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 00811311021000
• NIH Device Record Key: c83f1159-87be-4eff-9553-7cfe436e85b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter
• Version Model Number: SR-4535-BC
• Catalog Number: SR-4535-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: 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	00811311021000 [Primary]

FDA Product Code

• LIT: Catheter, Angioplasty, Peripheral, Transluminal

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-10-25
• Device Publish Date: 2022-11-01

On-Brand Devices [ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter]

• 00811311021031: 6mmx35mm
• 00811311021024: 5.5mmx35mm
• 00811311020966: 6mm X 25mm
• 00811311020959: 5.5mm X 25mm
• 00811311021017: 5mm X 35mm
• 00811311021000: 4.5mm X 35mm
• 00811311020997: 4mm X 35mm
• 00811311020942: 5mm X 25mm
• 00811311020935: 4.5mm X 25mm