NC SPRINTER®

GUDID 00643169282100

BALLOON NCSP4009X NCSPRINTER RX M US

MEDTRONIC, INC.

Coronary angioplasty balloon catheter, basic

• Primary Device ID: 00643169282100
• NIH Device Record Key: 0c4547bc-98f4-4068-99d7-fcddec1af366
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NC SPRINTER®
• Version Model Number: NCSP4009X
• 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: 9 Millimeter
• Length: 9 Millimeter
• Length: 9 Millimeter
• Length: 9 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169282100 [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

On-Brand Devices [NC SPRINTER®]

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• 00643169282353: BALLOON NCSP27509X NCSPRINTER RX M US
• 00643169282346: BALLOON NCSP27506X NCSPRINTER RX M US
• 00643169282339: BALLOON NCSP2527X NCSPRINTER RX M US
• 00643169282322: BALLOON NCSP2521X NCSPRINTER RX M US
• 00643169282315: BALLOON NCSP2515X NCSPRINTER RX M US
• 00643169282308: BALLOON NCSP2512X NCSPRINTER RX M US
• 00643169282292: BALLOON NCSP2509X NCSPRINTER RX M US
• 00643169282285: BALLOON NCSP2506X NCSPRINTER RX M US
• 00643169282261: BALLOON NCSP22521X NCSPRINTER RX M US
• 00643169282254: BALLOON NCSP22512X NCSPRINTER RX M US
• 00643169282247: BALLOON NCSP22506X NCSPRINTER RX M US
• 00643169282223: BALLOON NCSP2021X NCSPRINTER RX M US
• 00643169282216: BALLOON NCSP2015X NCSPRINTER RX M US
• 00643169282209: BALLOON NCSP2012X NCSPRINTER RX M US
• 00643169282193: BALLOON NCSP2009X NCSPRINTER RX M US
• 00643169282186: BALLOON NCSP2006X NCSPRINTER RX M US
• 00643169282179: BALLOON NCSP5015X NCSPRINTER RX M US
• 00643169282162: BALLOON NCSP4521X NCSPRINTER RX M US
• 00643169282155: BALLOON NCSP4515X NCSPRINTER RX M US
• 00643169282148: BALLOON NCSP4027X NCSPRINTER RX M US
• 00643169282131: BALLOON NCSP4021X NCSPRINTER RX M US
• 00643169282124: BALLOON NCSP4015X NCSPRINTER RX M US
• 00643169282117: BALLOON NCSP4012X NCSPRINTER RX M US
• 00643169282100: BALLOON NCSP4009X NCSPRINTER RX M US
• 00643169282094: BALLOON NCSP4006X NCSPRINTER RX M US
• 00643169282087: BALLOON NCSP37521X NCSPRINTER RX M US
• 00643169282070: BALLOON NCSP37515X NCSPRINTER RX M US
• 00643169282063: BALLOON NCSP37512X NCSPRINTER RX M US
• 00643169282056: BALLOON NCSP37509X NCSPRINTER RX M US
• 00643169282049: BALLOON NCSP37506X NCSPRINTER RX M US
• 00643169282032: BALLOON NCSP3527X NCSPRINTER RX M US
• 00643169282025: BALLOON NCSP3521X NCSPRINTER RX M US
• 00643169282018: BALLOON NCSP3515X NCSPRINTER RX M US
• 00643169282001: BALLOON NCSP3512X NCSPRINTER RX M US
• 00643169281998: BALLOON NCSP3509X NCSPRINTER RX M US
• 00643169281981: BALLOON NCSP3506X NCSPRINTER RX M US
• 00643169281974: BALLOON NCSP32521X NCSPRINTER RX M US
• 00643169281967: BALLOON NCSP32515X NCSPRINTER RX M US
• 00643169281950: BALLOON NCSP32512X NCSPRINTER RX M US
• 00643169281943: BALLOON NCSP32509X NCSPRINTER RX M US
• 00643169281936: BALLOON NCSP32506X NCSPRINTER RX M US
• 00643169281929: BALLOON NCSP3027X NCSPRINTER RX M US