PNS Wearable Accessory L/XL Horizontal

Basic Information

• Brand Name: PNS Wearable Accessory L/XL Horizontal
• Primary DI: 00818225021867
• Version / Model: 00-52003
• Company Name: STIMWAVE TECHNOLOGIES INCORPORATED
• Labeler DUNS: 078294927
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-14
• Public Version: 2
• Public Version Date: 2023-04-04
• Public Version Status: Update
• Public Device Record Key: 9ff362c7-c7f4-4d19-a511-e8bc68350e10

Device Description

Externally worn transmitter for the Wearable Antenna Assembly (WAA) to power the device.

Device Characteristics

• Single Use: No
• 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: No
• 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
37685	Personal device holder, reusable	A portable device designed to hold a portable medical device (e.g., long-term recorder, portable oxygen equipment, urine collection bag, tracheostoma protector, infusion pump) during ambulation or sleep; it is neither designed to hold an invasive tube/catheter to the skin surface (i.e., not a catheter/tube holder), nor to house and protect a device from damage (i.e., not a rigid case/housing). It is typically designed as a wearable bag, pouch, strap, belt, or clothing, or as a trolley with wheels. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00818225021867	GS1