Euphora™

GUDID 00643169559875

BALLOON EUP2010X EUPHORA RX US

MEDTRONIC, INC.

Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic

• Primary Device ID: 00643169559875
• NIH Device Record Key: 25a36ba2-43ba-46c4-9214-f5af3b32370b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Euphora™
• Version Model Number: EUP2010X
• 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

• Length: 10 Millimeter
• Length: 10 Millimeter
• Length: 10 Millimeter
• Length: 10 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169559875 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143480

FDA Product Code

• LOX: Catheters, transluminal coronary angioplasty, 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: 2019-10-07
• Device Publish Date: 2016-04-11

On-Brand Devices [Euphora™]

• 00643169560444: BALLOON EUP4030X EUPHORA RX US
• 00643169560437: BALLOON EUP4025X EUPHORA RX US
• 00643169560420: BALLOON EUP4020X EUPHORA RX US
• 00643169560413: BALLOON EUP4015X EUPHORA RX US
• 00643169560406: BALLOON EUP4012X EUPHORA RX US
• 00643169560390: BALLOON EUP4010X EUPHORA RX US
• 00643169560383: BALLOON EUP4006X EUPHORA RX US
• 00643169560376: BALLOON EUP37525X EUPHORA RX US
• 00643169560369: BALLOON EUP37520X EUPHORA RX US
• 00643169560352: BALLOON EUP37515X EUPHORA RX US
• 00643169560345: BALLOON EUP37512X EUPHORA RX US
• 00643169560338: BALLOON EUP37510X EUPHORA RX US
• 00643169560321: BALLOON EUP37506X EUPHORA RX US
• 00643169560314: BALLOON EUP3530X EUPHORA RX US
• 00643169560307: BALLOON EUP3525X EUPHORA RX US
• 00643169560291: BALLOON EUP3520X EUPHORA RX US
• 00643169560284: BALLOON EUP3515X EUPHORA RX US
• 00643169560277: BALLOON EUP3512X EUPHORA RX US
• 00643169560260: BALLOON EUP3510X EUPHORA RX US
• 00643169560253: BALLOON EUP3506X EUPHORA RX US
• 00643169560246: BALLOON EUP32525X EUPHORA RX US
• 00643169560239: BALLOON EUP32520X EUPHORA RX US
• 00643169560222: BALLOON EUP32515X EUPHORA RX US
• 00643169560215: BALLOON EUP32512X EUPHORA RX US
• 00643169560208: BALLOON EUP32510X EUPHORA RX US
• 00643169560192: BALLOON EUP32506X EUPHORA RX US
• 00643169560185: BALLOON EUP3030X EUPHORA RX US
• 00643169560178: BALLOON EUP3025X EUPHORA RX US
• 00643169560161: BALLOON EUP3020X EUPHORA RX US
• 00643169560154: BALLOON EUP3015X EUPHORA RX US
• 00643169560147: BALLOON EUP3012X EUPHORA RX US
• 00643169560130: BALLOON EUP3010X EUPHORA RX US
• 00643169560123: BALLOON EUP3006X EUPHORA RX US
• 00643169560116: BALLOON EUP27525X EUPHORA RX US
• 00643169560109: BALLOON EUP27520X EUPHORA RX US
• 00643169560093: BALLOON EUP27515X EUPHORA RX US
• 00643169560086: BALLOON EUP27512X EUPHORA RX US
• 00643169560079: BALLOON EUP27510X EUPHORA RX US
• 00643169560062: BALLOON EUP27506X EUPHORA RX US
• 00643169560055: BALLOON EUP2530X EUPHORA RX US
• 00643169560048: BALLOON EUP2525X EUPHORA RX US
• 00643169560031: BALLOON EUP2520X EUPHORA RX US
• 00643169560024: BALLOON EUP2515X EUPHORA RX US
• 00643169560017: BALLOON EUP2512X EUPHORA RX US
• 00643169560000: BALLOON EUP2510X EUPHORA RX US
• 00643169559998: BALLOON EUP2506X EUPHORA RX US
• 00643169559981: BALLOON EUP22525X EUPHORA RX US
• 00643169559974: BALLOON EUP22520X EUPHORA RX US
• 00643169559967: BALLOON EUP22515X EUPHORA RX US
• 00643169559950: BALLOON EUP22512X EUPHORA RX US