Omnia PTRC2300

GUDID 00813426020541

Patient Remote 2300 Kit

NEVRO CORP.

Implantable spinal cord electrical stimulation system programmer Implantable lumbar neuromuscular electrical stimulation system programmer Implantable lumbar neuromuscular electrical stimulation system programmer Implantable lumbar neuromuscular electrical stimulation system programmer Implantable lumbar neuromuscular electrical stimulation system programmer Implantable lumbar neuromuscular electrical stimulation system programmer Implantable lumbar neuromuscular electrical stimulation system programmer Implantable lumbar neuromuscular electrical stimulation system programmer Implantable lumbar neuromuscular electrical stimulation system programmer Implantable lumbar neuromuscular electrical stimulation system programmer Implantable lumbar neuromuscular electrical stimulation system programmer Implantable lumbar neuromuscular electrical stimulation system programmer Implantable lumbar neuromuscular electrical stimulation system programmer Implantable lumbar neuromuscular electrical stimulation system programmer Implantable lumbar neuromuscular electrical stimulation system programmer Implantable lumbar neuromuscular electrical stimulation system programmer Implantable lumbar neuromuscular electrical stimulation system programmer Spinal cord/peripheral nerve implantable analgesic electrical stimulation system programmer Spinal cord/peripheral nerve implantable analgesic electrical stimulation system programmer Spinal cord/peripheral nerve implantable analgesic electrical stimulation system programmer Spinal cord/peripheral nerve implantable analgesic electrical stimulation system programmer Spinal cord/peripheral nerve implantable analgesic electrical stimulation system programmer Spinal cord/peripheral nerve implantable analgesic electrical stimulation system programmer Spinal cord/peripheral nerve implantable analgesic electrical stimulation system programmer Spinal cord/peripheral nerve implantable analgesic electrical stimulation system programmer Spinal cord/peripheral nerve implantable analgesic electrical stimulation system programmer Spinal cord/peripheral nerve implantable analgesic electrical stimulation system programmer Spinal cord/peripheral nerve implantable analgesic electrical stimulation system programmer Spinal cord/peripheral nerve implantable analgesic electrical stimulation system programmer Spinal cord/peripheral nerve implantable analgesic electrical stimulation system programmer Spinal cord/peripheral nerve implantable analgesic electrical stimulation system programmer Spinal cord/peripheral nerve implantable analgesic electrical stimulation system programmer Spinal cord/peripheral nerve implantable analgesic electrical stimulation system programmer Spinal cord/peripheral nerve implantable analgesic electrical stimulation system programmer Spinal cord/peripheral nerve implantable analgesic electrical stimulation system programmer Spinal cord/peripheral nerve implantable analgesic electrical stimulation system programmer Spinal cord/peripheral nerve implantable analgesic electrical stimulation system programmer Spinal cord/peripheral nerve implantable analgesic electrical stimulation system programmer Spinal cord/peripheral nerve implantable analgesic electrical stimulation system programmer Spinal cord/peripheral nerve implantable analgesic electrical stimulation system programmer Spinal cord/peripheral nerve implantable analgesic electrical stimulation system programmer Spinal cord/peripheral nerve implantable analgesic 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