StimRouter User Kit

Basic Information

• Brand Name: StimRouter User Kit
• Primary DI: 00815962021464
• Version / Model: ST2-5050
• Company Name: BIONESS INC.
• Labeler DUNS: 182287727
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-17
• Public Version: 1
• Public Version Date: 2022-10-25
• Public Version Status: New
• Public Device Record Key: 6d02eb4c-83ac-4e02-8685-c0471b27d79e

Device Description

External Electrical Field Conductor

Device Characteristics

• Single Use: Yes
• 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: No
• 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
GZF	Stimulator, peripheral nerve, implanted (pain relief)	Neurology	882.5870	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65532	Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, extracorporeal	An electrically-powered, external (noninvasive) component of a spinal cord/peripheral nerve implantable analgesic electrical stimulation system intended to generate electrical impulses, for wireless (transcutaneous) transmission, to an implantable lead (situated adjacent to the epidural space and/or a peripheral nerve), to relieve acute and/or chronic intractable pain (analgesia); the implantable lead is not included. It is designed for continuous therapy (i.e., not a trial therapy device). The device is programmed, controlled, and charged by external devices which may be included with the device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00815962021464	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -25 – 60 Degrees Celsius