NC Stormer™ OTW

GUDID 00643169850286

BALLOON NCS4016W NC STORMER OTW

MEDTRONIC, INC.

Coronary angioplasty balloon catheter, basic

• Primary Device ID: 00643169850286
• NIH Device Record Key: bd11e3d8-c556-4770-aaf2-0cc73a1fc056
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NC Stormer™ OTW
• Version Model Number: NCS4016W
• 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: 16 Millimeter
• Length: 16 Millimeter
• Length: 16 Millimeter
• Length: 16 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169850286 [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: 2017-11-13

On-Brand Devices [NC Stormer™ OTW]

• 00643169850309: BALLOON NCS4021W NC STORMER OTW
• 00643169850293: BALLOON NCS4018W NC STORMER OTW
• 00643169850286: BALLOON NCS4016W NC STORMER OTW
• 00643169850279: BALLOON NCS4014W NC STORMER OTW
• 00643169850262: BALLOON NCS4011W NC STORMER OTW
• 00643169850255: BALLOON NCS4006W NC STORMER OTW
• 00643169850248: BALLOON NCS37521W NC STORMER OTW
• 00643169850231: BALLOON NCS37518W NC STORMER OTW
• 00643169850224: BALLOON NCS37516W NC STORMER OTW
• 00643169850217: BALLOON NCS37514W NC STORMER OTW
• 00643169850200: BALLOON NCS37511W NC STORMER OTW
• 00643169850194: BALLOON NCS37506W NC STORMER OTW
• 00643169850187: BALLOON NCS3521W NC STORMER OTW
• 00643169850170: BALLOON NCS3518W NC STORMER OTW
• 00643169850163: BALLOON NCS3516W NC STORMER OTW
• 00643169850156: BALLOON NCS3514W NC STORMER OTW
• 00643169850149: BALLOON NCS3511W NC STORMER OTW
• 00643169850132: BALLOON NCS3506W NC STORMER OTW
• 00643169850125: BALLOON NCS32521W NC STORMER OTW
• 00643169850118: BALLOON NCS32518W NC STORMER OTW
• 00643169850101: BALLOON NCS32516W NC STORMER OTW
• 00643169850095: BALLOON NCS32514W NC STORMER OTW
• 00643169850088: BALLOON NCS32511W NC STORMER OTW
• 00643169850071: BALLOON NCS32506W NC STORMER OTW
• 00643169850064: BALLOON NCS3031W NC STORMER OTW
• 00643169850057: BALLOON NCS3026W NC STORMER OTW
• 00643169850040: BALLOON NCS3021W NC STORMER OTW
• 00643169850033: BALLOON NCS3018W NC STORMER OTW
• 00643169850026: BALLOON NCS3016W NC STORMER OTW
• 00643169850019: BALLOON NCS3014W NC STORMER OTW
• 00643169850002: BALLOON NCS3011W NC STORMER OTW
• 00643169849990: BALLOON NCS3006W NC STORMER OTW
• 00643169849983: BALLOON NCS27521W NC STORMER OTW
• 00643169849976: BALLOON NCS27518W NC STORMER OTW
• 00643169849969: BALLOON NCS27516W NC STORMER OTW
• 00643169849952: BALLOON NCS27514W NC STORMER OTW
• 00643169849945: BALLOON NCS27511W NC STORMER OTW
• 00643169849938: BALLOON NCS27506W NC STORMER OTW
• 00643169849921: BALLOON NCS2531W NC STORMER OTW
• 00643169849914: BALLOON NCS2526W NC STORMER OTW
• 00643169849907: BALLOON NCS2521W NC STORMER OTW
• 00643169849891: BALLOON NCS2518W NC STORMER OTW
• 00643169849884: BALLOON NCS2516W NC STORMER OTW
• 00643169849877: BALLOON NCS2514W NC STORMER OTW
• 00643169849860: BALLOON NCS2511W NC STORMER OTW
• 00643169849853: BALLOON NCS2506W NC STORMER OTW
• 00643169849846: BALLOON NCS22521W NC STORMER OTW
• 00643169849839: BALLOON NCS22516W NC STORMER OTW
• 00643169849822: BALLOON NCS22511W NC STORMER OTW
• 00643169849815: BALLOON NCS22506W NC STORMER OTW