Omnia

Basic Information

• Brand Name: Omnia
• Primary DI: 00813426020541
• Version / Model: PTRC2300
• Catalog Number: PTRC2300
• Company Name: NEVRO CORP.
• Labeler DUNS: 926599155
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-11-11
• Public Version: 5
• Public Version Date: 2021-06-08
• Public Version Status: Update
• Public Device Record Key: 065d6ff3-4741-4c12-bf8a-e671c2a3fe97

Device Description

Patient Remote 2300 Kit

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LGW	Stimulator, Spinal-Cord, Totally Implanted For Pain Relief	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
62425	Spinal cord/peripheral nerve implantable analgesic electrical stimulation system programmer	A portable, electrically-powered component of a spinal cord/peripheral nerve implantable analgesic electrical stimulation system intended to be used by a healthcare professional to program the pulse generator component with patient-specific parameters; a tester and/or dedicated software may be included. The system is designed to deliver episodic electrical stimulation to the epidural space of the spinal cord and/or in/near a peripheral nerve (e.g., lumbar, truncal, in a limb) for the relief/treatment of acute and/or chronic intractable pain [e.g., chronic low back pain (CLBP)].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00813426020541	GS1

Premarket Submissions

Submission Number	Supplement Number
P130022	000