Spur Peripheral Retrievable Stent System

GUDID 00850025525169

Peripheral Retrievable Stent System; 3mm x 65mm, catheter shaft length 135cm

REFLOW MEDICAL, INC.

Peripheral artery stent, bare-metal

• Primary Device ID: 00850025525169
• NIH Device Record Key: 5b10b590-24e5-4657-bab3-683ebf4dec80
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spur Peripheral Retrievable Stent System
• Version Model Number: BSPUR365135US
• Company DUNS: 962545294
• Company Name: REFLOW 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com

Device Dimensions

• Stent Diameter: 3 Millimeter
• Stent Length: 65 Millimeter
• Shaft Length: 135 Centimeter
• Stent Diameter: 3 Millimeter
• Stent Length: 65 Millimeter
• Shaft Length: 135 Centimeter
• Stent Diameter: 3 Millimeter
• Stent Length: 65 Millimeter
• Shaft Length: 135 Centimeter
• Stent Diameter: 3 Millimeter
• Stent Length: 65 Millimeter
• Shaft Length: 135 Centimeter
• Stent Diameter: 3 Millimeter
• Stent Length: 65 Millimeter
• Shaft Length: 135 Centimeter
• Stent Diameter: 3 Millimeter
• Stent Length: 65 Millimeter
• Shaft Length: 135 Centimeter
• Stent Diameter: 3 Millimeter
• Stent Length: 65 Millimeter
• Shaft Length: 135 Centimeter
• Stent Diameter: 3 Millimeter
• Stent Length: 65 Millimeter
• Shaft Length: 135 Centimeter
• Stent Diameter: 3 Millimeter
• Stent Length: 65 Millimeter
• Shaft Length: 135 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850025525169 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN240048

FDA Product Code

• SEU: Peripheral Temporary And Retrievable Stent System

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: 2025-06-16
• Device Publish Date: 2025-06-06

On-Brand Devices [Spur Peripheral Retrievable Stent System]

• 00850025525176: Peripheral Retrievable Stent System; 4mm x 60mm, catheter shaft length 135cm
• 00850025525169: Peripheral Retrievable Stent System; 3mm x 65mm, catheter shaft length 135cm