InterStim iCon

GUDID 00613994639639

PROGRAMMER 3037 INTERSTIM PATIENT BOWEL

MEDTRONIC, INC.

Neuromuscular electrical stimulation system programmer

• Primary Device ID: 00613994639639
• NIH Device Record Key: 3aa04eef-5596-45e1-becf-1cc9d310cd2e
• 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
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994639639 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P080025

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: 2014-09-23

On-Brand Devices [InterStim iCon]

• 00613994639639: PROGRAMMER 3037 INTERSTIM PATIENT BOWEL
• 00613994572059: PRGMR 3037 INTERSTIM PATIENT SW UPDATE