NC SPRINTER®

GUDID 00643169282254

BALLOON NCSP22512X NCSPRINTER RX M US

MEDTRONIC, INC.

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

• Primary Device ID: 00643169282254
• NIH Device Record Key: 88a420d3-3525-414e-b4ff-28f036b08226
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NC SPRINTER®
• Version Model Number: NCSP22512X
• 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: 2.25 Millimeter
• Outer Diameter: 2.25 Millimeter
• Outer Diameter: 2.25 Millimeter
• Outer Diameter: 2.25 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169282254 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P790017

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: 2016-04-17

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• 00643169282025: BALLOON NCSP3521X NCSPRINTER RX M US
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