InterStim iCon®

GUDID 00643169860728

PROG 3037 INTERSTM PATIENT US PTG UPDATE

MEDTRONIC, INC.

Implantable incontinence-control electrical stimulation system programmer, battery-powered

• Primary Device ID: 00643169860728
• NIH Device Record Key: cf768722-40a9-4a00-a591-6bb98e33ab8c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InterStim iCon®
• Version Model Number: 3037
• 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: false
• Single Use: false
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169860728 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P970004

FDA Product Code

• EZW: Stimulator, electrical, implantable, for incontinence

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-10-07

On-Brand Devices [InterStim iCon®]

• 00643169860728: PROG 3037 INTERSTM PATIENT US PTG UPDATE
• 00643169518940: PROG 3037 INTRSTIM II PATIENT ROHS