PowerCross AB18W060100090

GUDID 00821684046463

.018

Covidien LP

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 00821684046463
• NIH Device Record Key: 6d80b29c-476a-4186-ab21-6d844433b10a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PowerCross
• Version Model Number: AB18W060100090
• Catalog Number: AB18W060100090
• 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: true
• 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(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 100 Millimeter
• Outer Diameter: 6 Millimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Length: 100 Millimeter
• Outer Diameter: 6 Millimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Length: 100 Millimeter
• Outer Diameter: 6 Millimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Length: 100 Millimeter
• Outer Diameter: 6 Millimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Length: 100 Millimeter
• Outer Diameter: 6 Millimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Length: 100 Millimeter
• Outer Diameter: 6 Millimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Length: 100 Millimeter
• Outer Diameter: 6 Millimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Length: 100 Millimeter
• Outer Diameter: 6 Millimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Length: 100 Millimeter
• Outer Diameter: 6 Millimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821684046463 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093286

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: 2015-10-09

On-Brand Devices [PowerCross]

• 00821684046913: .018
• 00821684046906: .018
• 00821684046890: .018
• 00821684046883: .018
• 00821684046876: .018
• 00821684046869: .018
• 00821684046852: .018
• 00821684046845: .018
• 00821684046838: .018
• 00821684046821: .018
• 00821684046814: .018
• 00821684046807: .018
• 00821684046791: .018
• 00821684046784: .018
• 00821684046777: .018
• 00821684046760: .018
• 00821684046753: .018
• 00821684046746: .018
• 00821684046739: .018
• 00821684046722: .018
• 00821684046715: .018
• 00821684046708: .018
• 00821684046692: .018
• 00821684046685: .018
• 00821684046678: .018
• 00821684046661: .018
• 00821684046654: .018
• 00821684046647: .018
• 00821684046630: .018
• 00821684046623: .018
• 00821684046616: .018
• 00821684046609: .018
• 00821684046593: .018
• 00821684046586: .018
• 00821684046579: .018
• 00821684046562: .018
• 00821684046555: .018
• 00821684046548: .018
• 00821684046531: .018
• 00821684046524: .018
• 00821684046517: .018
• 00821684046500: .018
• 00821684046494: .018
• 00821684046487: .018
• 00821684046470: .018
• 00821684046463: .018
• 00821684046456: .018
• 00821684046449: .018
• 00821684046432: .018
• 00821684046425: .018