Sprinter Legend™

GUDID 00643169854956

BLN SPL12512WL SPR LEGEND 1.25X12 OTW US

MEDTRONIC, INC.

Coronary angioplasty balloon catheter, basic

• Primary Device ID: 00643169854956
• NIH Device Record Key: e0276543-3e89-4009-ae25-01acec3ab9f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sprinter Legend™
• Version Model Number: SPL12512WL
• 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: 12 Millimeter
• Length: 12 Millimeter
• Length: 12 Millimeter
• Length: 12 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169854956 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103095

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 Legend™]

• 00643169854970: BLN SPL12520WL SPR LEGEND 1.25X20 OTW US
• 00643169854963: BLN SPL12515WL SPR LEGEND 1.25X15 OTW US
• 00643169854956: BLN SPL12512WL SPR LEGEND 1.25X12 OTW US
• 00643169854949: BLN SPL12510WL SPR LEGEND 1.25X10 OTW US
• 00643169854932: BLN SPL12506WL SPR LEGEND 1.25X6 OTW US