Sprinter™

GUDID 00643169850392

BALLOON SPR2015W SPRINTER OTW 2.0X15MM

MEDTRONIC, INC.

Coronary angioplasty balloon catheter, basic

• Primary Device ID: 00643169850392
• NIH Device Record Key: fe4d828f-a3f3-40f9-bf89-7c4412aaa854
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sprinter™
• Version Model Number: SPR2015W
• 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: 15 Millimeter
• Length: 15 Millimeter
• Length: 15 Millimeter
• Length: 15 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169850392 [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: 2018-01-14

On-Brand Devices [Sprinter™]

• 00643169850842: BALLOON SPR4030W SPRINTER OTW 4.0X30MM
• 00643169850835: BALLOON SPR4025W SPRINTER OTW 4.0X25MM
• 00643169850828: BALLOON SPR4020W SPRINTER OTW 4.0X20MM
• 00643169850811: BALLOON SPR4015W SPRINTER OTW 4.0X15MM
• 00643169850804: BALLOON SPR4012W SPRINTER OTW 4.0X12MM
• 00643169850798: 4.0MM X 10MM SPRINTER OTW BALLOON DILATA
• 00643169850781: BALLOON SPR4006W SPRINTER OTW 4.0X6MM
• 00643169850774: BALLOON SPR37520W SPRINTER OTW 3.75X20MM
• 00643169850767: BALLOON SPR37515W SPRINTER OTW 3.75X15MM
• 00643169850750: BALLOON SPR37512W SPRINTER OTW 3.75X12MM
• 00643169850743: BALLOON SPR3530W SPRINTER OTW 3.5X30MM
• 00643169850736: BALLOON SPR3525W SPRINTER OTW 3.5X25MM
• 00643169850729: BALLOON SPR3520W SPRINTER OTW 3.5X20MM
• 00643169850712: BALLOON SPR3515W SPRINTER OTW 3.5X15MM
• 00643169850705: BALLOON SPR3512W SPRINTER OTW 3.5X12MM
• 00643169850699: 3.5MM X 10MM SPRINTER OTW BALLOON DILATA
• 00643169850682: BALLOON SPR3506W SPRINTER OTW 3.5X6MM
• 00643169850675: BALLOON SPR32520W SPRINTER OTW 3.25X20MM
• 00643169850668: BALLOON SPR32515W SPRINTER OTW 3.25X15MM
• 00643169850651: BALLOON SPR32512W SPRINTER OTW 3.25X12MM
• 00643169850644: BALLOON SPR3030W SPRINTER OTW 3.0X30MM
• 00643169850637: BALLOON SPR3025W SPRINTER OTW 3.0X25MM
• 00643169850620: BALLOON SPR3020W SPRINTER OTW 3.0X20MM
• 00643169850613: BALLOON SPR3015W SPRINTER OTW 3.0X15MM
• 00643169850606: BALLOON SPR3012W SPRINTER OTW 3.0X12MM
• 00643169850590: 3.0MM X 10MM SPRINTER OTW BALLOON DILATA
• 00643169850583: BALLOON SPR3006W SPRINTER OTW 3.0X6MM
• 00643169850576: BALLOON SPR27520W SPRINTER OTW 2.75X20MM
• 00643169850569: BALLOON SPR27515W SPRINTER OTW 2.75X15MM
• 00643169850552: BALLOON SPR27512W SPRINTER OTW 2.75X12MM
• 00643169850545: BALLOON SPR27506W SPRINTER OTW 2.75X6MM
• 00643169850538: BALLOON SPR2530W SPRINTER OTW 2.5X30MM
• 00643169850521: BALLOON SPR2525W SPRINTER OTW 2.5X25MM
• 00643169850514: BALLOON SPR2520W SPRINTER OTW 2.5X20MM
• 00643169850507: BALLOON SPR2515W SPRINTER OTW 2.5X15MM
• 00643169850491: BALLOON SPR2512W SPRINTER OTW 2.5X12MM
• 00643169850484: BALLOON SPR2510W SPRINTER OTW 2.5X10MM
• 00643169850477: BALLOON SPR2506W SPRINTER OTW 2.5X6MM
• 00643169850460: BALLOON SPR22520W SPRINTER OTW 2.25X20MM
• 00643169850453: BALLOON SPR22515W SPRINTER OTW 2.25X15MM
• 00643169850446: BALLOON SPR22512W SPRINTER OTW 2.25X12MM
• 00643169850439: BALLOON SPR22506W SPRINTER OTW 2.25X6MM
• 00643169850422: BALLOON SPR2030W SPRINTER OTW 2.0X30MM
• 00643169850415: BALLOON SPR2025W SPRINTER OTW 2.0X25MM
• 00643169850408: BALLOON SPR2020W SPRINTER OTW 2.0X20MM
• 00643169850392: BALLOON SPR2015W SPRINTER OTW 2.0X15MM
• 00643169850385: BALLOON SPR2012W SPRINTER OTW 2.0X12MM
• 00643169850378: BALLOON SPR2010W SPRINTER OTW 2.0X10MM
• 00643169850361: BALLOON SPR2006W SPRINTER OTW 2.0X6MM
• 00643169850354: BALLOON SPR1520W SPRINTER OTW 1.5X20MM