StimRouter User Kit

Basic Information

• Brand Name: StimRouter User Kit
• Primary DI: 00815962020030
• Version / Model: ST2-5000
• Company Name: BIONESS INC.
• Labeler DUNS: 182287727
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-19
• Public Version: 5
• Public Version Date: 2021-09-20
• Public Version Status: Update
• Public Device Record Key: ba2d7f00-9a90-4a0d-8959-4230fb82f98a

Device Description

External Pulse Transmitter (EPT)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• 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
GZF	STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF)	Neurology	882.5870	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60960	Analgesic PENS system probe, single-use	A sterile, hand-held electrical conductor intended to be used as part of an analgesic percutaneous electrical nerve stimulation (PENS) system to deliver controlled electrical impulses directly to subcutaneous tissue for the relief of chronic neuropathic pain. It is intended to be connected to an analgesic PENS system generator and its conductive length introduced percutaneously (invasively) into the patient, in the vicinity of a peripheral nerve. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00815962020030	GS1

Customer Contacts

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