Senza®

GUDID 00813426020497

Programmer Kit 2500

NEVRO CORP.

Implantable spinal cord electrical stimulation system programmer

• Primary Device ID: 00813426020497
• NIH Device Record Key: 92e6ebd9-61d3-46a3-a9ce-eb86d74d4c6d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Senza®
• Version Model Number: CLPG2500
• Company DUNS: 926599155
• Company Name: NEVRO CORP.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813426020497 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P130022

FDA Product Code

• LGW: Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

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: 2017-04-28

On-Brand Devices [Senza®]

• 00813426020497: Programmer Kit 2500
• 00813426020169: Senza® Patient Trial Kit
• 00813426020152: Senza® Trial Stimulator Kit
• 00813426020121: Senza® Charger Kit
• 00813426020114: Patient Remote Kit
• 00813426020015: Senza® IPG Kit
• 00813426020008: Senza IPG Kit
• 00813426020534: Charger Belt Kit
• 00813426020527: Charger Power Supply Kit