NURO™

GUDID 00643169654624

ENS 3533 NURO EXTERNAL NEUROSTIMULATOR

MEDTRONIC, INC.

Tibial nerve percutaneous incontinence-control electrical stimulation system

• Primary Device ID: 00643169654624
• NIH Device Record Key: 54caaf37-8802-47b9-82a4-7835df83fd2e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NURO™
• Version Model Number: 3533
• 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 -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169654624 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132561

FDA Product Code

• NAM: STIMULATOR,PERIPHERAL NERVE,NON-IMPLANTED,FOR PELVIC FLOOR DYSFUNCTION

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: 2016-03-31

On-Brand Devices [NURO™]

• 00643169654631: ACCY 3533K THERAPY SESSION KIT
• 00643169654624: ENS 3533 NURO EXTERNAL NEUROSTIMULATOR
• 00763000157487: ENS 3533A NURO EXTRNL NEUROSTIMULATOR US