EverCross™

GUDID 00763000765958

PTA AB35W03120080 EVERCROSS 035 V10

MEDTRONIC, INC.

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• Primary Device ID: 00763000765958
• NIH Device Record Key: d60213f6-dad9-4881-bea8-c7048d228edb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EverCross™
• Version Model Number: AB35W03120080
• 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

Device Dimensions

• Device Size Text, specify: 0
• Catheter Working Length: 80 Centimeter
• Balloon Length: 120 Millimeter
• Balloon Diameter: 3 Millimeter
• Device Size Text, specify: 0
• Catheter Working Length: 80 Centimeter
• Balloon Length: 120 Millimeter
• Balloon Diameter: 3 Millimeter
• Device Size Text, specify: 0
• Catheter Working Length: 80 Centimeter
• Balloon Length: 120 Millimeter
• Balloon Diameter: 3 Millimeter
• Device Size Text, specify: 0
• Catheter Working Length: 80 Centimeter
• Balloon Length: 120 Millimeter
• Balloon Diameter: 3 Millimeter
• Device Size Text, specify: 0
• Catheter Working Length: 80 Centimeter
• Balloon Length: 120 Millimeter
• Balloon Diameter: 3 Millimeter
• Device Size Text, specify: 0
• Catheter Working Length: 80 Centimeter
• Balloon Length: 120 Millimeter
• Balloon Diameter: 3 Millimeter
• Device Size Text, specify: 0
• Catheter Working Length: 80 Centimeter
• Balloon Length: 120 Millimeter
• Balloon Diameter: 3 Millimeter
• Device Size Text, specify: 0
• Catheter Working Length: 80 Centimeter
• Balloon Length: 120 Millimeter
• Balloon Diameter: 3 Millimeter
• Device Size Text, specify: 0
• Catheter Working Length: 80 Centimeter
• Balloon Length: 120 Millimeter
• Balloon Diameter: 3 Millimeter
• Device Size Text, specify: 0
• Catheter Working Length: 80 Centimeter
• Balloon Length: 120 Millimeter
• Balloon Diameter: 3 Millimeter
• Device Size Text, specify: 0
• Catheter Working Length: 80 Centimeter
• Balloon Length: 120 Millimeter
• Balloon Diameter: 3 Millimeter
• Device Size Text, specify: 0
• Catheter Working Length: 80 Centimeter
• Balloon Length: 120 Millimeter
• Balloon Diameter: 3 Millimeter
• Device Size Text, specify: 0
• Catheter Working Length: 80 Centimeter
• Balloon Length: 120 Millimeter
• Balloon Diameter: 3 Millimeter
• Device Size Text, specify: 0
• Catheter Working Length: 80 Centimeter
• Balloon Length: 120 Millimeter
• Balloon Diameter: 3 Millimeter
• Device Size Text, specify: 0
• Catheter Working Length: 80 Centimeter
• Balloon Length: 120 Millimeter
• Balloon Diameter: 3 Millimeter
• Device Size Text, specify: 0
• Catheter Working Length: 80 Centimeter
• Balloon Length: 120 Millimeter
• Balloon Diameter: 3 Millimeter
• Device Size Text, specify: 0
• Catheter Working Length: 80 Centimeter
• Balloon Length: 120 Millimeter
• Balloon Diameter: 3 Millimeter
• Device Size Text, specify: 0
• Catheter Working Length: 80 Centimeter
• Balloon Length: 120 Millimeter
• 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
• 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	00763000765958 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190753

FDA Product Code

• DQY: Catheter, percutaneous

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: 2024-03-15
• Device Publish Date: 2024-03-07

On-Brand Devices [EverCross™]

• 00763000767228: PTA AB35W12060135 EVERCROSS 035 V10
• 00763000767211: PTA AB35W12060080 EVERCROSS 035 V10
• 00763000767204: PTA AB35W12040135 EVERCROSS 035 V10
• 00763000767198: PTA AB35W12040080 EVERCROSS 035 V10
• 00763000767181: PTA AB35W12020135 EVERCROSS 035 V10
• 00763000767174: PTA AB35W12020080 EVERCROSS 035 V10
• 00763000767167: PTA AB35W10060135 EVERCROSS 035 V10
• 00763000767150: PTA AB35W10060080 EVERCROSS 035 V10
• 00763000767143: PTA AB35W10040135 EVERCROSS 035 V10
• 00763000767136: PTA AB35W10040080 EVERCROSS 035 V10
• 00763000767129: PTA AB35W10030135 EVERCROSS 035 V10
• 00763000767112: PTA AB35W10030080 EVERCROSS 035 V10
• 00763000767105: PTA AB35W10020135 EVERCROSS 035 V10
• 00763000767099: PTA AB35W10020080 EVERCROSS 035 V10
• 00763000767082: PTA AB35W09080135 EVERCROSS 035 V10
• 00763000767075: PTA AB35W09080080 EVERCROSS 035 V10
• 00763000767068: PTA AB35W09060135 EVERCROSS 035 V10
• 00763000767051: PTA AB35W09060080 EVERCROSS 035 V10
• 00763000767044: PTA AB35W09040135 EVERCROSS 035 V10
• 00763000767037: PTA AB35W09040080 EVERCROSS 035 V10
• 00763000767020: PTA AB35W09030135 EVERCROSS 035 V10
• 00763000767013: PTA AB35W09030080 EVERCROSS 035 V10
• 00763000767006: PTA AB35W09020135 EVERCROSS 035 V10
• 00763000766993: PTA AB35W09020080 EVERCROSS 035 V10
• 00763000766986: PTA AB35W08080135 EVERCROSS 035 V10
• 00763000766979: PTA AB35W08080080 EVERCROSS 035 V10
• 00763000766962: PTA AB35W08060135 EVERCROSS 035 V10
• 00763000766955: PTA AB35W08060080 EVERCROSS 035 V10
• 00763000766948: PTA AB35W08060040 EVERCROSS 035 V10
• 00763000766931: PTA AB35W08040135 EVERCROSS 035 V10
• 00763000766924: PTA AB35W08040080 EVERCROSS 035 V10
• 00763000766917: PTA AB35W08040040 EVERCROSS 035 V10
• 00763000766900: PTA AB35W08030135 EVERCROSS 035 V10
• 00763000766894: PTA AB35W08030080 EVERCROSS 035 V10
• 00763000766887: PTA AB35W08020135 EVERCROSS 035 V10
• 00763000766870: PTA AB35W08020080 EVERCROSS 035 V10
• 00763000766863: PTA AB35W08020040 EVERCROSS 035 V10
• 00763000766856: PTA AB35W07200135 EVERCROSS 035 V10
• 00763000766849: PTA AB35W07200080 EVERCROSS 035 V10
• 00763000766832: PTA AB35W07150135 EVERCROSS 035 V10
• 00763000766825: PTA AB35W07150080 EVERCROSS 035 V10
• 00763000766818: PTA AB35W07120135 EVERCROSS 035 V10
• 00763000766801: PTA AB35W07120080 EVERCROSS 035 V10
• 00763000766795: PTA AB35W07100135 EVERCROSS 035 V10
• 00763000766788: PTA AB35W07100080 EVERCROSS 035 V10
• 00763000766771: PTA AB35W07080135 EVERCROSS 035 V10
• 00763000766764: PTA AB35W07080080 EVERCROSS 035 V10
• 00763000766757: PTA AB35W07060135 EVERCROSS 035 V10
• 00763000766740: PTA AB35W07060080 EVERCROSS 035 V10
• 00763000766733: PTA AB35W07060040 EVERCROSS 035 V10