INDURA®

GUDID 00613994586056

CATH 8709SC 1PC SUTURLESS US (TRAY)

MEDTRONIC, INC.

General-purpose implantable infusion pump, programmable General-purpose implantable infusion pump, programmable

• Primary Device ID: 00613994586056
• NIH Device Record Key: de40e600-ecb3-47a9-befe-99c57d42b3a8
• Commercial Distribution Discontinuation: 2017-03-06
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: INDURA®
• Version Model Number: 8709SC
• Company DUNS: 796986144
• 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: true
• Single Use: true
• Lot Batch: false
• Serial Number: true
• 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

• Length: 81.4 Centimeter
• Length: 81.4 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994586056 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P860004

FDA Product Code

• LKK: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-04-27

On-Brand Devices [INDURA®]

• 00613994586056: CATH 8709SC 1PC SUTURLESS US (TRAY)
• 00613994586032: CATH 8711 2PC CLSD TIP JAPAN US (TRAY)