Chocolate®

GUDID 00763000240394

PTA CB1415030080 CHOCOLATE 014 V02

MEDTRONIC, INC.

Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 00763000240394
• NIH Device Record Key: a37f428e-ca83-4143-a195-d15d0cc76a9e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Chocolate®
• Version Model Number: CB1415030080OTW
• 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
• 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
• 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
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3 Millimeter
• Device Size Text, specify: 0
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3 Millimeter
• Device Size Text, specify: 0
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3 Millimeter
• Device Size Text, specify: 0
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3 Millimeter
• Device Size Text, specify: 0
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3 Millimeter
• Device Size Text, specify: 0
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3 Millimeter
• Device Size Text, specify: 0
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3 Millimeter
• Device Size Text, specify: 0
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3 Millimeter
• Device Size Text, specify: 0
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3 Millimeter
• Device Size Text, specify: 0
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3 Millimeter
• Device Size Text, specify: 0
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3 Millimeter
• Device Size Text, specify: 0
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3 Millimeter
• Device Size Text, specify: 0
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3 Millimeter
• Device Size Text, specify: 0
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3 Millimeter
• Device Size Text, specify: 0
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3 Millimeter
• Device Size Text, specify: 0
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3 Millimeter
• Device Size Text, specify: 0
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3 Millimeter
• Device Size Text, specify: 0
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3 Millimeter
• Device Size Text, specify: 0
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3 Millimeter
• Device Size Text, specify: 0
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3 Millimeter
• Device Size Text, specify: 0
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3 Millimeter
• Device Size Text, specify: 0
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3 Millimeter
• Device Size Text, specify: 0
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3 Millimeter
• Device Size Text, specify: 0
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3 Millimeter
• Device Size Text, specify: 0
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3 Millimeter
• Device Size Text, specify: 0
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3 Millimeter
• Device Size Text, specify: 0
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3 Millimeter
• Device Size Text, specify: 0
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3 Millimeter
• Device Size Text, specify: 0
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3 Millimeter
• Device Size Text, specify: 0
• Length: 150 Centimeter
• Device Size Text, specify: 0

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.
• 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	00763000240394 [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: 2019-10-28
• Device Publish Date: 2019-10-20

On-Brand Devices [Chocolate®]

• 00763000240462: PTA CB1812060120 CHOCOLATE 018 V02
• 00763000240455: PTA CB1812060080 CHOCOLATE 018 V02
• 00763000240448: PTA CB1812060040 CHOCOLATE 018 V02
• 00763000240431: PTA CB1812050120 CHOCOLATE 018 V02
• 00763000240424: PTA CB1812050080 CHOCOLATE 018 V02
• 00763000240417: PTA CB1812050040 CHOCOLATE 018 V02
• 00763000240400: PTA CB1415030120 CHOCOLATE 014 V02
• 00763000240394: PTA CB1415030080 CHOCOLATE 014 V02
• 00763000240387: PTA CB1415030040 CHOCOLATE 014 V02
• 00763000240370: PTA CB1415025120 CHOCOLATE 014 V02
• 00763000240363: PTA CB1415025080 CHOCOLATE 014 V02
• 00763000240356: PTA CB1415025040 CHOCOLATE 014 V02
• 00763000240349: PTA CB1413540120 CHOCOLATE 014 V02
• 00763000240332: PTA CB1413540080 CHOCOLATE 014 V02
• 00763000240325: PTA CB1413540040 CHOCOLATE 014 V02
• 00763000240318: PTA CB1413535120 CHOCOLATE 014 V02
• 00763000240301: PTA CB1413535080 CHOCOLATE 014 V02
• 00763000240295: PTA CB1413535040 CHOCOLATE 014 V02