Senza SW-10043

GUDID 00813426020817

HFX iQ Patient Application (iOS)

NEVRO CORP.

Implantable electrical stimulation device management software

• Primary Device ID: 00813426020817
• NIH Device Record Key: da7852fc-7daa-4567-bae7-c0342473ad4d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Senza
• Version Model Number: SW-10043
• Catalog Number: SW-10043
• Company DUNS: 926599155
• Company Name: NEVRO CORP.
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813426020817 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-16
• Device Publish Date: 2023-03-08

On-Brand Devices [Senza]

• 00813426020701: Bluetooth Patient Remote kit
• 00813426020695: Extra Battery kit
• 00813426020688: Magnet Kit
• 00813426020671: TSM Pouch Kit
• 00813426020664: Bluetooth Trial stimulator kit
• 00813426020763: Blue Lead Kit, 70cm with 5mm Spacing, Curved Stylet .016"
• 00813426020756: Blue Lead Kit, 90cm with 5mm Spacing, Curved Stylet .016"
• 00813426020749: Trial Lead Kit, 70cm with 5mm Spacing, Curved Stylet .016"
• 00813426020732: Trial Lead Kit, 50cm with 5mm Spacing, Curved Stylet .016"
• 00813426020725: Blue Lead Kit, 50cm with 5mm Spacing, Curved Stylet .016"
• 00813426020718: IPG Model IPG3000 Kit, NIPG3000
• 00081342602077: Trial Stimulatory 3500 Kit
• 00813426020770: Trial Stimulator 3500 Kit
• 00813426020817: HFX iQ Patient Application (iOS)
• 00813426021067: Gaea Cryptofunction