NC Euphora™

GUDID 00643169395855

BALLOON NCEUP3015X NCEUPHORA RX US

MEDTRONIC, INC.

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

• Primary Device ID: 00643169395855
• NIH Device Record Key: 3a4d3031-ccfb-4866-83a4-f28942003541
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NC Euphora™
• Version Model Number: NCEUP3015X
• 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

• Outer Diameter: 3 Millimeter
• Outer Diameter: 3 Millimeter
• Outer Diameter: 3 Millimeter
• Outer Diameter: 3 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169395855 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141090

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: 2016-04-24

On-Brand Devices [NC Euphora™]

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• 00643169396210: BALLOON NCEUP4015X NCEUPHORA RX US
• 00643169396203: BALLOON NCEUP4020X NCEUPHORA RX US
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• 00643169396142: BALLOON NCEUP2520X NCEUPHORA RX US
• 00643169396135: BALLOON NCEUP2527X NCEUPHORA RX US
• 00643169396128: BALLOON NCEUP27506X NCEUPHORA RX US
• 00643169396111: BALLOON NCEUP27508X NCEUPHORA RX US
• 00643169396104: BALLOON NCEUP5012X NCEUPHORA RX US
• 00643169396098: BALLOON NCEUP5015X NCEUPHORA RX US
• 00643169396081: BALLOON NCEUP4520X NCEUPHORA RX US
• 00643169396074: BALLOON NCEUP5008X NCEUPHORA RX US
• 00643169396067: BALLOON NCEUP3506X NCEUPHORA RX US
• 00643169396050: BALLOON NCEUP22508X NCEUPHORA RX US
• 00643169396043: BALLOON NCEUP22512X NCEUPHORA RX US
• 00643169396036: BALLOON NCEUP22515X NCEUPHORA RX US
• 00643169396029: BALLOON NCEUP22520X NCEUPHORA RX US
• 00643169395954: BALLOON NCEUP2506X NCEUPHORA RX US
• 00643169395947: BALLOON NCEUP2508X NCEUPHORA RX US
• 00643169395930: BALLOON NCEUP2512X NCEUPHORA RX US
• 00643169395923: BALLOON NCEUP27512X NCEUPHORA RX US
• 00643169395916: BALLOON NCEUP27515X NCEUPHORA RX US
• 00643169395909: BALLOON NCEUP27520X NCEUPHORA RX US
• 00643169395893: BALLOON NCEUP27527X NCEUPHORA RX US
• 00643169395886: BALLOON NCEUP3006X NCEUPHORA RX US
• 00643169395879: BALLOON NCEUP3008X NCEUPHORA RX US
• 00643169395862: BALLOON NCEUP3012X NCEUPHORA RX US