GUDID 20643169014217

INTRDCR 663311 10PK 6F PE DILATOR 11CM

MEDTRONIC, INC.

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 20643169014217
• NIH Device Record Key: ba0e4223-02c0-43ce-b465-1c7669ea1c8f
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 663311
• 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: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 6 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 6 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 6 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 6 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 6 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 6 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 6 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 6 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 6 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 6 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 6 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 6 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 6 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 6 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 6 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 6 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 6 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169014213 [Primary]
GS1	20643169014217 [Package]; Contains: 00643169014213; Package: PK [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132617

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: 2017-02-02

Devices Manufactured by MEDTRONIC, INC.

• 00199150007172 - NA: 2025-04-21 CUSTOM PACK PDBB11V44R10 CORE PIX
• 00199150007547 - NA: 2025-04-21 CUSTOM PACK SSBB10Z49R20 NEW CONFIG
• 00763000812041 - NA: 2025-04-21 CAP 5867-3M STERILE MDR
• 00763000812058 - NA: 2025-04-21 SERVICE KIT 5873C LEAD MDR
• 00763000947064 - Bio-Medicus™: 2025-04-21 CANNULA 96530-115 BIO-MEDICUS 15FR
• 00763000947071 - Bio-Medicus™: 2025-04-21 CANNULA 96530-117 BIO-MEDICUS 17FR
• 00763000947088 - Bio-Medicus™: 2025-04-21 CANNULA 96530-119 BIO-MEDICUS 19FR
• 00763000947095 - Bio-Medicus™: 2025-04-21 CANNULA 96530-121 BIO-MEDICUS 21FR