NanoCross™

GUDID 00821684059340

PTA AB14W020210150 NANOCROSS 014 V03

Covidien LP

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: 00821684059340
• NIH Device Record Key: 52c7e906-246f-4eeb-a4c5-375cc8616926
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NanoCross™
• Version Model Number: AB14W020210150
• Company DUNS: 968903703
• Company Name: Covidien LP
• 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

Device Dimensions

• Outer Diameter: 2 Millimeter
• Outer Diameter: 2 Millimeter
• Outer Diameter: 2 Millimeter
• Outer Diameter: 2 Millimeter
• Length: 210 Millimeter
• Outer Diameter: 2 Millimeter
• Length: 210 Millimeter
• Outer Diameter: 2 Millimeter
• Length: 210 Millimeter
• Outer Diameter: 2 Millimeter
• Length: 210 Millimeter
• Outer Diameter: 2 Millimeter
• Length: 210 Millimeter
• Outer Diameter: 2 Millimeter
• Length: 210 Millimeter
• Outer Diameter: 2 Millimeter
• Length: 210 Millimeter
• Outer Diameter: 2 Millimeter
• Length: 210 Millimeter
• Outer Diameter: 2 Millimeter
• Length: 210 Millimeter
• Outer Diameter: 2 Millimeter
• Length: 210 Millimeter
• Outer Diameter: 2 Millimeter
• Length: 210 Millimeter
• Outer Diameter: 2 Millimeter
• Length: 210 Millimeter
• Outer Diameter: 2 Millimeter
• Length: 210 Millimeter
• Outer Diameter: 2 Millimeter
• Length: 210 Millimeter
• Outer Diameter: 2 Millimeter
• Length: 210 Millimeter
• Outer Diameter: 2 Millimeter
• Length: 210 Millimeter
• Outer Diameter: 2 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• 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	00821684059340 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082854

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: 4
• Public Version Date: 2019-08-09
• Device Publish Date: 2016-04-21

On-Brand Devices [NanoCross™]

• 00821684059821: PTA AB14W040210150 NANOCROSS 014 V03
• 00821684059814: PTA AB14W040210090 NANOCROSS 014 V03
• 00821684059807: PTA AB14W040150150 NANOCROSS 014 V03
• 00821684059791: PTA AB14W040150090 NANOCROSS 014 V03
• 00821684059784: PTA AB14W040120150 NANOCROSS 014 V03
• 00821684059777: PTA AB14W040120090 NANOCROSS 014 V03
• 00821684059760: PTA AB14W040080150 NANOCROSS 014 V03
• 00821684059753: PTA AB14W040080090 NANOCROSS 014 V03
• 00821684059746: PTA AB14W040040150 NANOCROSS 014 V03
• 00821684059739: PTA AB14W040040090 NANOCROSS 014 V03
• 00821684059722: PTA AB14W040020150 NANOCROSS 014 V03
• 00821684059715: PTA AB14W040020090 NANOCROSS 014 V03
• 00821684059708: PTA AB14W035210150 NANOCROSS 014 V03
• 00821684059692: PTA AB14W035210090 NANOCROSS 014 V03
• 00821684059685: PTA AB14W035150150 NANOCROSS 014 V03
• 00821684059678: PTA AB14W035150090 NANOCROSS 014 V03
• 00821684059661: PTA AB14W035120150 NANOCROSS 014 V03
• 00821684059654: PTA AB14W035120090 NANOCROSS 014 V03
• 00821684059647: PTA AB14W035080150 NANOCROSS 014 V03
• 00821684059630: PTA AB14W035080090 NANOCROSS 014 V03
• 00821684059623: PTA AB14W035040150 NANOCROSS 014 V03
• 00821684059616: PTA AB14W035040090 NANOCROSS 014 V03
• 00821684059609: PTA AB14W035020150 NANOCROSS 014 V03
• 00821684059593: PTA AB14W035020090 NANOCROSS 014 V03
• 00821684059586: PTA AB14W030210150 NANOCROSS 014 V03
• 00821684059579: PTA AB14W030210090 NANOCROSS 014 V03
• 00821684059562: PTA AB14W030150150 NANOCROSS 014 V03
• 00821684059555: PTA AB14W030150090 NANOCROSS 014 V03
• 00821684059548: PTA AB14W030120150 NANOCROSS 014 V03
• 00821684059531: PTA AB14W030120090 NANOCROSS 014 V03
• 00821684059524: PTA AB14W030080150 NANOCROSS 014 V03
• 00821684059517: PTA AB14W030080090 NANOCROSS 014 V03
• 00821684059500: PTA AB14W030040150 NANOCROSS 014 V03
• 00821684059494: PTA AB14W030040090 NANOCROSS 014 V03
• 00821684059487: PTA AB14W030020150 NANOCROSS 014 V03
• 00821684059470: PTA AB14W030020090 NANOCROSS 014 V03
• 00821684059463: PTA AB14W025210150 NANOCROSS 014 V03
• 00821684059456: PTA AB14W025210090 NANOCROSS 014 V03
• 00821684059449: PTA AB14W025150150 NANOCROSS 014 V03
• 00821684059432: PTA AB14W025150090 NANOCROSS 014 V03
• 00821684059425: PTA AB14W025120150 NANOCROSS 014 V03
• 00821684059418: PTA AB14W025120090 NANOCROSS 014 V03
• 00821684059401: PTA AB14W025080150 NANOCROSS 014 V03
• 00821684059395: PTA AB14W025080090 NANOCROSS 014 V03
• 00821684059388: PTA AB14W025040150 NANOCROSS 014 V03
• 00821684059371: PTA AB14W025040090 NANOCROSS 014 V03
• 00821684059364: PTA AB14W025020150 NANOCROSS 014 V03
• 00821684059357: PTA AB14W025020090 NANOCROSS 014 V03
• 00821684059340: PTA AB14W020210150 NANOCROSS 014 V03
• 00821684059333: PTA AB14W020210090 NANOCROSS 014 V03