Chocolate® PTA Balloon Catheter

GUDID 00763000115258

PTA CB1812060040 CHOCOLATE 018

MEDTRONIC, INC.

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 00763000115258
• NIH Device Record Key: b5352ade-2d35-432c-b5b5-8134b8acdfb0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Chocolate® PTA Balloon Catheter
• Version Model Number: CB1812060040OTW
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, cool place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000115258 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130414

FDA Product Code

• LIT: Catheter, angioplasty, peripheral, transluminal

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-08-09
• Device Publish Date: 2018-05-27

On-Brand Devices [Chocolate® PTA Balloon Catheter]

• 00763000115272: PTA CB1812060120 CHOCOLATE 018
• 00763000115265: PTA CB1812060080 CHOCOLATE 018
• 00763000115258: PTA CB1812060040 CHOCOLATE 018
• 00763000115241: PTA CB1812050120 CHOCOLATE 018
• 00763000115234: PTA CB1812050080 CHOCOLATE 018
• 00763000115227: PTA CB1812050040 CHOCOLATE 018
• 00763000115210: PTA CB1415030120 CHOCOLATE 014
• 00763000115203: PTA CB1415030080 CHOCOLATE 014
• 00763000115197: PTA CB1415030040 CHOCOLATE 014
• 00763000115180: PTA CB1415025120 CHOCOLATE 014
• 00763000115173: PTA CB1415025080 CHOCOLATE 014
• 00763000115166: PTA CB1415025040 CHOCOLATE 014
• 00763000115159: PTA CB1413540120 CHOCOLATE 014
• 00763000115142: PTA CB1413540080 CHOCOLATE 014
• 00763000115135: PTA CB1413540040 CHOCOLATE 014
• 00763000115128: PTA CB1413535120 CHOCOLATE 014
• 00763000115111: PTA CB1413535080 CHOCOLATE 014
• 00763000115104: PTA CB1413535040 CHOCOLATE 014