GUDID 00643169014718

INTRODUCER 008591 8F TRAN CATH INTRO SET

MEDTRONIC, INC.

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 00643169014718
• NIH Device Record Key: 7d30a360-be64-4ff1-aaab-c53e094dfa0c
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 008591
• 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
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Outer Diameter: 0.81 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Outer Diameter: 0.81 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Outer Diameter: 0.81 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Outer Diameter: 0.81 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Outer Diameter: 0.81 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Outer Diameter: 0.81 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Outer Diameter: 0.81 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Outer Diameter: 0.81 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Outer Diameter: 0.81 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Outer Diameter: 0.81 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Outer Diameter: 0.81 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Outer Diameter: 0.81 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Outer Diameter: 0.81 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Outer Diameter: 0.81 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Outer Diameter: 0.81 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Outer Diameter: 0.81 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Outer Diameter: 0.81 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169014718 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K791963

FDA Product Code

• DYB: INTRODUCER, CATHETER

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: 2019-06-07
• Device Publish Date: 2016-12-30

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