Senza®

Basic Information

• Brand Name: Senza®
• Primary DI: 00813426020121
• Version / Model: CHGR1000
• Catalog Number: CHGR1000
• Company Name: NEVRO CORP.
• Labeler DUNS: 926599155
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-05-21
• Public Version: 5
• Public Version Date: 2021-01-22
• Public Version Status: Update
• Public Device Record Key: 986dbdd5-8eeb-439c-ae82-92186b01bbc0

Device Description

Senza® Charger Kit

Device Characteristics

• Single Use: No
• 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: 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
33658	Implant battery charger	An electronic device intended to be used to wirelessly recharge the batteries of an active implantable device in situ. It is not intended to program or extract data from (read) the implanted device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00813426020121	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P130022	000