DuraTENS

Basic Information

• Brand Name: DuraTENS
• Primary DI: 10009336010223
• Version / Model: 700000548
• Catalog Number: 700000548
• Company Name: GRAPHIC CONTROLS ACQUISITION CORP
• Labeler DUNS: 002111896
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2022-04-11
• Public Version: 2
• Public Version Date: 2022-05-19
• Public Version Status: Update
• Public Device Record Key: 717578c6-fbdd-442e-ae43-0519b2e8066e

Device Description

Supplier PN: R50100C2WF-T Neurostimulation Electrode

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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: No
• 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
GXY	Electrode, Cutaneous	Neurology	882.1320	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65318	Transcutaneous electrical stimulation electrode, reusable	An electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation (EMS), cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30009336010227	GS1	Box	60	In Commercial Distribution
Primary	10009336010223	GS1
Package	50009336010221	GS1	Case/Master Carton	1800	In Commercial Distribution
Unit of Use	00009336010226	GS1

Customer Contacts

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