Chocolate®

GUDID 00763000336660

PTA CB1413540080 CHOCOLATE 014 V03

EV3, INC

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 00763000336660
• NIH Device Record Key: 4d8382d5-8cc5-466c-9b10-b514b603e538
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Chocolate®
• Version Model Number: CB1413540080OTW
• Company DUNS: 117446916
• Company Name: EV3, 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
• 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

• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Length: 80 Millimeter

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000336660 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-06-23
• Device Publish Date: 2020-06-15

On-Brand Devices [Chocolate®]

• 00763000336790: PTA CB1812060120 CHOCOLATE 018 V03
• 00763000336783: PTA CB1812060080 CHOCOLATE 018 V03
• 00763000336776: PTA CB1812060040 CHOCOLATE 018 V03
• 00763000336769: PTA CB1812050120 CHOCOLATE 018 V03
• 00763000336752: PTA CB1812050080 CHOCOLATE 018 V03
• 00763000336745: PTA CB1812050040 CHOCOLATE 018 V03
• 00763000336738: PTA CB1415030120 CHOCOLATE 014 V03
• 00763000336721: PTA CB1415030080 CHOCOLATE 014 V03
• 00763000336714: PTA CB1415030040 CHOCOLATE 014 V03
• 00763000336707: PTA CB1415025120 CHOCOLATE 014 V03
• 00763000336691: PTA CB1415025080 CHOCOLATE 014 V03
• 00763000336684: PTA CB1415025040 CHOCOLATE 014 V03
• 00763000336677: PTA CB1413540120 CHOCOLATE 014 V03
• 00763000336660: PTA CB1413540080 CHOCOLATE 014 V03
• 00763000336653: PTA CB1413540040 CHOCOLATE 014 V03
• 00763000336646: PTA CB1413535120 CHOCOLATE 014 V03
• 00763000336639: PTA CB1413535080 CHOCOLATE 014 V03
• 00763000336622: PTA CB1413535040 CHOCOLATE 014 V03
• 00763000430580: PTA CB1812060120 CHOCOLATE 018 V04
• 00763000430573: PTA CB1812060080 CHOCOLATE 018 V04
• 00763000430566: PTA CB1812060040 CHOCOLATE 018 V04
• 00763000430559: PTA CB1812050120 CHOCOLATE 018 V04
• 00763000430542: PTA CB1812050080 CHOCOLATE 018 V04
• 00763000430535: PTA CB1812050040 CHOCOLATE 018 V04
• 00763000430528: PTA CB1415030120 CHOCOLATE 014 V04
• 00763000430511: PTA CB1415030080 CHOCOLATE 014 V04
• 00763000430504: PTA CB1415030040 CHOCOLATE 014 V04
• 00763000430498: PTA CB1415025120 CHOCOLATE 014 V04
• 00763000430481: PTA CB1415025080 CHOCOLATE 014 V04
• 00763000430474: PTA CB1415025040 CHOCOLATE 014 V04
• 00763000430467: PTA CB1413540120 CHOCOLATE 014 V04
• 00763000430450: PTA CB1413540080 CHOCOLATE 014 V04
• 00763000430443: PTA CB1413540040 CHOCOLATE 014 V04
• 00763000430436: PTA CB1413535120 CHOCOLATE 014 V04
• 00763000430429: PTA CB1413535080 CHOCOLATE 014 V04
• 00763000430412: PTA CB1413535040 CHOCOLATE 014 V04