NanoCross™ Elite

GUDID 00763000757595

PTA AB14W030060090 NANOCROSS 014 V06

MEDTRONIC, INC.

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 00763000757595
• NIH Device Record Key: 8435f719-a82d-468e-a19b-6138e4d16cd2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NanoCross™ Elite
• Version Model Number: AB14W030060090
• 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

Device Dimensions

• Balloon Length: 60 Millimeter
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Balloon Diameter: 3 Millimeter
• Balloon Length: 60 Millimeter
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Balloon Diameter: 3 Millimeter
• Balloon Length: 60 Millimeter
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Balloon Diameter: 3 Millimeter
• Balloon Length: 60 Millimeter
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Balloon Diameter: 3 Millimeter
• Balloon Length: 60 Millimeter
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Balloon Diameter: 3 Millimeter
• Balloon Length: 60 Millimeter
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Balloon Diameter: 3 Millimeter
• Balloon Length: 60 Millimeter
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Balloon Diameter: 3 Millimeter
• Balloon Length: 60 Millimeter
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Balloon Diameter: 3 Millimeter
• Balloon Length: 60 Millimeter
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Balloon Diameter: 3 Millimeter
• Balloon Length: 60 Millimeter
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Balloon Diameter: 3 Millimeter
• Balloon Length: 60 Millimeter
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Balloon Diameter: 3 Millimeter
• Balloon Length: 60 Millimeter
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Balloon Diameter: 3 Millimeter
• Balloon Length: 60 Millimeter
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Balloon Diameter: 3 Millimeter
• Balloon Length: 60 Millimeter
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Balloon Diameter: 3 Millimeter
• Balloon Length: 60 Millimeter
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Balloon Diameter: 3 Millimeter
• Balloon Length: 60 Millimeter
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Balloon Diameter: 3 Millimeter
• Balloon Length: 60 Millimeter
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Balloon Diameter: 3 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000757595 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141118

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: 2024-03-18
• Device Publish Date: 2024-03-08

On-Brand Devices [NanoCross™ Elite]

• 00763000758349: PTA AB14W060200150 NANOCROSS 014 V06
• 00763000758332: PTA AB14W060200090 NANOCROSS 014 V06
• 00763000758325: PTA AB14W060150150 NANOCROSS 014 V06
• 00763000758318: PTA AB14W060150090 NANOCROSS 014 V06
• 00763000758301: PTA AB14W060120150 NANOCROSS 014 V06
• 00763000758295: PTA AB14W060120090 NANOCROSS 014 V06
• 00763000758288: PTA AB14W060100150 NANOCROSS 014 V06
• 00763000758271: PTA AB14W060100090 NANOCROSS 014 V06
• 00763000758264: PTA AB14W060080150 NANOCROSS 014 V06
• 00763000758257: PTA AB14W060080090 NANOCROSS 014 V06
• 00763000758240: PTA AB14W060060150 NANOCROSS 014 V06
• 00763000758233: PTA AB14W060060090 NANOCROSS 014 V06
• 00763000758226: PTA AB14W060040150 NANOCROSS 014 V06
• 00763000758219: PTA AB14W060040090 NANOCROSS 014 V06
• 00763000758202: PTA AB14W060020150 NANOCROSS 014 V06
• 00763000758196: PTA AB14W060020090 NANOCROSS 014 V06
• 00763000758189: PTA AB14W050200150 NANOCROSS 014 V06
• 00763000758172: PTA AB14W050200090 NANOCROSS 014 V06
• 00763000758165: PTA AB14W050150150 NANOCROSS 014 V06
• 00763000758158: PTA AB14W050150090 NANOCROSS 014 V06
• 00763000758141: PTA AB14W050120150 NANOCROSS 014 V06
• 00763000758134: PTA AB14W050120090 NANOCROSS 014 V06
• 00763000758127: PTA AB14W050100150 NANOCROSS 014 V06
• 00763000758110: PTA AB14W050100090 NANOCROSS 014 V06
• 00763000758103: PTA AB14W050080150 NANOCROSS 014 V06
• 00763000758097: PTA AB14W050080090 NANOCROSS 014 V06
• 00763000758080: PTA AB14W050060150 NANOCROSS 014 V06
• 00763000758073: PTA AB14W050060090 NANOCROSS 014 V06
• 00763000758066: PTA AB14W050040150 NANOCROSS 014 V06
• 00763000758059: PTA AB14W050040090 NANOCROSS 014 V06
• 00763000758042: PTA AB14W050020150 NANOCROSS 014 V06
• 00763000758035: PTA AB14W050020090 NANOCROSS 014 V06
• 00763000758028: PTA AB14W040210150 NANOCROSS 014 V06
• 00763000758011: PTA AB14W040210090 NANOCROSS 014 V06
• 00763000758004: PTA AB14W040150150 NANOCROSS 014 V06
• 00763000757991: PTA AB14W040150090 NANOCROSS 014 V06
• 00763000757984: PTA AB14W040120150 NANOCROSS 014 V06
• 00763000757977: PTA AB14W040120090 NANOCROSS 014 V06
• 00763000757960: PTA AB14W040100150 NANOCROSS 014 V06
• 00763000757953: PTA AB14W040100090 NANOCROSS 014 V06
• 00763000757946: PTA AB14W040080150 NANOCROSS 014 V06
• 00763000757939: PTA AB14W040080090 NANOCROSS 014 V06
• 00763000757922: PTA AB14W040060150 NANOCROSS 014 V06
• 00763000757915: PTA AB14W040060090 NANOCROSS 014 V06
• 00763000757908: PTA AB14W040040150 NANOCROSS 014 V06
• 00763000757892: PTA AB14W040040090 NANOCROSS 014 V06
• 00763000757885: PTA AB14W040020150 NANOCROSS 014 V06
• 00763000757878: PTA AB14W040020090 NANOCROSS 014 V06
• 00763000757861: PTA AB14W035210150 NANOCROSS 014 V06
• 00763000757854: PTA AB14W035210090 NANOCROSS 014 V06