Reliant™

GUDID 00643169707641

CATHETER REL46 US RELIANT BALLOON

MEDTRONIC, INC.

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 00643169707641
• NIH Device Record Key: 99e091e5-457e-47b5-8718-b875ef46dcf2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reliant™
• Version Model Number: REL46
• Company DUNS: 006261481
• Company Name: MEDTRONIC, 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: false
• 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: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169707641 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050038

FDA Product Code

• DQY: CATHETER, PERCUTANEOUS

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-08-09
• Device Publish Date: 2017-02-24

On-Brand Devices [Reliant™]

• 00643169707641: CATHETER REL46 US RELIANT BALLOON
• 00763000154134: CATHETER REL46 US RELIANT BALLOON
• 00763000200947: CATHETER REL46 US RELIANT BALLOON