SPRINTER® LEGEND

GUDID 00613994901965

BLN SPL35012X SPR LEG 3.5X12 RX US M

MEDTRONIC, INC.

Coronary angioplasty balloon catheter, basic

• Primary Device ID: 00613994901965
• NIH Device Record Key: 8d2e1f42-d8fe-45f2-8dc0-16b909f84aa4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPRINTER® LEGEND
• Version Model Number: SPL35012X
• 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	00613994901965 [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: 2016-04-25

On-Brand Devices [SPRINTER® LEGEND]

• 00613994902924: BLN SPL22525X SPR LEG 2.25X25 RX US M
• 00613994902894: BLN SPL25006X SPR LEG 2.5X6 RX US M
• 00613994902863: BLN SPL25010X SPR LEG 2.5X10 RX US M
• 00613994902832: BLN SPL25012X SPR LEG 2.5X12 RX US M
• 00613994902801: BLN SPL22512X SPR LEG 2.25X12 RX US M
• 00613994902771: BLN SPL22515X SPR LEG 2.25X15 RX US M
• 00613994902740: BLN SPL22520X SPR LEG 2.25X20 RX US M
• 00613994902689: BLN SPL27506X SPR LEG 2.75X6 RX US M
• 00613994902658: BLN SPL27512X SPR LEG 2.75X12 RX US M
• 00613994902627: BLN SPL27515X SPR LEG 2.75X15 RX US M
• 00613994902597: BLN SPL25015X SPR LEG 2.5X15 RX US M
• 00613994902566: BLN SPL25020X SPR LEG 2.5X20 RX US M
• 00613994902535: BLN SPL25025X SPR LEG 2.5X25 RX US M
• 00613994902504: BLN SPL25030X SPR LEG 2.5X30 RX US M
• 00613994902498: BLN SPL15015X SPR LEG 1.5X15 RX US M
• 00613994902467: BLN SPL15020X SPR LEG 1.5X20 RX US M
• 00613994902436: BLN SPL20006X SPR LEG 2.0X6 RX US M
• 00613994902405: BLN SPL20010X SPR LEG 2.0X10 RX US M
• 00613994902375: BLN SPL15006X SPR LEG 1.5X6 RX US M
• 00613994902344: BLN SPL15010X SPR LEG 1.5X10 RX US M
• 00613994902313: BLN SPL15012X SPR LEG 1.5X12 RX US M
• 00613994902276: BLN SPL20025X SPR LEG 2.0X25 RX US M
• 00613994902245: BLN SPL20030X SPR LEG 2.0X30 RX US M
• 00613994902214: BLN SPL22506X SPR LEG 2.25X6 RX US M
• 00613994902184: BLN SPL22510X SPR LEG 2.25X10 RX US M
• 00613994902153: BLN SPL20012X SPR LEG 2.0X12 RX US M
• 00613994902122: BLN SPL20015X SPR LEG 2.0X15 RX US M
• 00613994902092: BLN SPL20020X SPR LEG 2.0X20 RX US M
• 00613994902054: BLN SPL35030X SPR LEG 3.5X30 RX US M
• 00613994902023: BLN SPL37512X SPR LEG 3.75X12 RX US M
• 00613994901996: BLN SPL37515X SPR LEG 3.75X15 RX US M
• 00613994901965: BLN SPL35012X SPR LEG 3.5X12 RX US M
• 00613994901934: BLN SPL35015X SPR LEG 3.5X15 RX US M
• 00613994901903: BLN SPL35020X SPR LEG 3.5X20 RX US M
• 00613994901873: BLN SPL35025X SPR LEG 3.5X25 RX US M
• 00613994901859: BLN SPL37520X SPR LEG 3.75X20 RX US M
• 00613994901842: BLN SPL40015X SPR LEG 4.0X15 RX US M
• 00613994901811: BLN SPL40020X SPR LEG 4.0X20 RX US M
• 00613994901781: BLN SPL40025X SPR LEG 4.0X25 RX US M
• 00613994901750: BLN SPL40030X SPR LEG 4.0X30 RX US M
• 00613994901729: BLN SPL40006X SPR LEG 4.0X6 RX US M
• 00613994901699: BLN SPL40010X SPR LEG 4.0X10 RX US M
• 00613994901668: BLN SPL40012X SPR LEG 4.0X12 RX US M
• 00613994901613: BLN SPL30012X SPR LEG 3.0X12 RX US M
• 00613994901583: BLN SPL30015X SPR LEG 3.0X15 RX US M
• 00613994901552: BLN SPL30020X SPR LEG 3.0X20 RX US M
• 00613994901521: BLN SPL27520X SPR LEG 2.75X20 RX US M
• 00613994901491: BLN SPL27525X SPR LEG 2.75X25 RX US M
• 00613994901460: BLN SPL30006X SPR LEG 3.0X6 RX US M
• 00613994901439: BLN SPL30010X SPR LEG 3.0X10 RX US M