RapidCross™

GUDID 00821684067932

PTA A14BX040150090 RAPIDCROSS V03

Covidien LP

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 00821684067932
• NIH Device Record Key: 8ddf80eb-3f52-4028-ad8a-f472afd8a426
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RapidCross™
• Version Model Number: A14BX040150090
• 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

Device Dimensions

• Outer Diameter: 4 Millimeter
• Outer Diameter: 4 Millimeter
• Outer Diameter: 4 Millimeter
• Outer Diameter: 4 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821684067932 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130911

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: 2016-04-16

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