Omnia PTRC2300

GUDID 00813426020541

Patient Remote 2300 Kit

NEVRO CORP.

Implantable spinal cord electrical stimulation system programmer

• Primary Device ID: 00813426020541
• NIH Device Record Key: 065d6ff3-4741-4c12-bf8a-e671c2a3fe97
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omnia
• Version Model Number: PTRC2300
• Catalog Number: PTRC2300
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813426020541 [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: 2
• Public Version Date: 2020-01-22
• Device Publish Date: 2019-11-11

On-Brand Devices [Omnia]

• 00813426020602: NIPG2500
• 00813426020626: Charger 2500 Power Supply Kit
• 00813426020619: Charger 2500 Belt Kit
• 00813426020565: Charger 2500 Kit
• 00813426020541: Patient Remote 2300 Kit
• 00813426020558: Patient Remote 2500 Kit
• 00813426020572: Senza II IPG Kit