Nevro®

Basic Information

• Brand Name: Nevro®
• Primary DI: 00813426020343
• Version / Model: ACCK9100
• Catalog Number: ACCK9100
• 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: 4
• Public Version Date: 2020-06-05
• Public Version Status: Update
• Public Device Record Key: e3d600f1-d8e0-47c3-81f4-ef84ce4e5422

Device Description

Medical Adhesive Kit

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: Labeling does not contain MRI Safety Information
• 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: 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
46219	Medical device adhesive	A substance primarily intended to promote the bonding of two surfaces in the manufacture of medical devices (e.g., active implantable devices). After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00813426020343	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P130022	000