RACER® BILIARY

GUDID 00613994551535

STENT XD512YL RACER US LONG

MEDTRONIC, INC.

Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent

• Primary Device ID: 00613994551535
• NIH Device Record Key: 2f47ace5-a875-4d98-a4f1-49fdb08b1152
• Commercial Distribution Discontinuation: 2018-10-05
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: RACER® BILIARY
• Version Model Number: XD512YL
• Company DUNS: 006261481
• Company Name: MEDTRONIC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994551535 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032768

FDA Product Code

• FGE: CATHETER, BILIARY, DIAGNOSTIC

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: 2019-01-23
• Device Publish Date: 2015-06-08

On-Brand Devices [RACER® BILIARY]

• 00613994551580: STENT XD412YF RACER US SHORT
• 00613994551573: STENT XD412YL RACER US LONG
• 00613994551566: STENT XD418YF RACER US SHORT
• 00613994551559: STENT XD418YL RACER US LONG
• 00613994551542: STENT XD512YF RACER US SHORT
• 00613994551535: STENT XD512YL RACER US LONG
• 00613994551528: STENT XD518YF RACER US SHORT
• 00613994551511: STENT XD518YL RACER US LONG
• 00613994551504: STENT XD612YF RACER US SHORT
• 00613994551498: STENT XD612YL RACER US LONG
• 00613994551481: STENT XD618YF RACER US SHORT
• 00613994551474: STENT XD618YL RACER US LONG
• 00613994551467: STENT XD712YF RACER US SHORT
• 00613994551450: STENT XD712YL RACER US LONG
• 00613994551443: STENT XD718YF RACER US SHORT
• 00613994551436: STENT XD718YL RACER US LONG