SINC

GUDID 00850025525220

REFLOW MEDICAL, INC.

Vascular guide-catheter, single-use

• Primary Device ID: 00850025525220
• NIH Device Record Key: 48540fef-efd2-42ed-8ced-a5f233365eff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SINC
• Version Model Number: SINC35135US
• 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

Device Dimensions

• Catheter Working Length: 135 Centimeter
• Catheter Working Length: 135 Centimeter
• Catheter Working Length: 135 Centimeter
• Catheter Working Length: 135 Centimeter
• Catheter Working Length: 135 Centimeter
• Catheter Working Length: 135 Centimeter
• Catheter Working Length: 135 Centimeter
• Catheter Working Length: 135 Centimeter
• Catheter Working Length: 135 Centimeter
• Catheter Working Length: 135 Centimeter
• Catheter Working Length: 135 Centimeter
• Catheter Working Length: 135 Centimeter
• Catheter Working Length: 135 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850025525220 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233350

FDA Product Code

• DQY: Catheter, Percutaneous

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: 2024-02-27
• Device Publish Date: 2024-02-19

On-Brand Devices [SINC]

• 00850025525220: SINC35135US
• 00850025525213: The SINC™ (Selective Interventional Navigation Catheter) Support Catheters are single lumen ca