Senza® NIPG1000

GUDID 00813426020008

Senza IPG Kit

NEVRO CORP.

Analgesic spinal cord electrical stimulation system

• Primary Device ID: 00813426020008
• NIH Device Record Key: cff739ed-d67c-4c70-9456-987f754ece45
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Senza®
• Version Model Number: NIPG1000
• Catalog Number: NIPG1000
• Company DUNS: 926599155
• Company Name: NEVRO CORP.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 6502510005
• Email: info@nevro.com
• Phone: 6502510005
• Email: info@nevro.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813426020008 [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: 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: 2015-05-21

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