Stedi™

GUDID 00763000978662

GUIDEWIRE STEDI-4 COMM US 10L

MEDTRONIC, INC.

Cardiac/peripheral vascular guidewire, single-use

• Primary Device ID: 00763000978662
• NIH Device Record Key: 39917c22-1ab1-4302-81a7-444920dd2a51
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stedi™
• Version Model Number: STEDI-4
• Company DUNS: 006261481
• Company Name: MEDTRONIC, INC.
• Device Count: 5
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Length: 275 Centimeter
• Outer Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Length: 275 Centimeter
• Outer Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Length: 275 Centimeter
• Outer Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Length: 275 Centimeter
• Outer Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Length: 275 Centimeter
• Outer Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Length: 275 Centimeter
• Outer Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Length: 275 Centimeter
• Outer Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Length: 275 Centimeter
• Outer Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Length: 275 Centimeter
• Outer Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Length: 275 Centimeter
• Outer Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Length: 275 Centimeter
• Outer Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Length: 275 Centimeter
• Outer Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Length: 275 Centimeter
• Outer Diameter: 0.035 Inch
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000978662 [Unit of Use]
GS1	20763000978666 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250075

FDA Product Code

• DQX: Wire, guide, catheter

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: 2025-07-28
• Device Publish Date: 2025-07-18

On-Brand Devices [Stedi™]

• 00763000978662: GUIDEWIRE STEDI-4 COMM US 10L
• 00763000978655: GUIDEWIRE STEDI-3 COMM US 10L