Nevro®

Basic Information

• Brand Name: Nevro®
• Primary DI: 00813426020404
• Version / Model: LEAD3005-70B
• Catalog Number: LEAD3005-70B
• Company Name: NEVRO CORP.
• Labeler DUNS: 926599155
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-20
• Public Version: 6
• Public Version Date: 2021-06-08
• Public Version Status: Update
• Public Device Record Key: fb21d618-2ff6-4de7-8bc5-7aafe1ae5bd4
• Distribution End Date: 2017-09-08

Device Description

Surgical Lead Kit, 70cm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• 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
62423	Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection	An electrically-insulated wire with a distal electrode intended to be implanted into the epidural space of the spinal cord and/or in/near a peripheral nerve (e.g., lumbar, truncal, in a limb) for wired transmission of electrical impulses from a co-implanted pulse generator (not included), to the target nerves, for the relief/treatment of acute and/or chronic intractable pain.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00813426020404	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P130022	004