WINNER EVO PACKAGE

Basic Information

• Brand Name: WINNER EVO PACKAGE
• Primary DI: 00852515007261
• Version / Model: 410-016
• Company Name: COMPASS HEALTH BRANDS CORP.
• Labeler DUNS: 827221698
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-11-21
• Public Version: 8
• Public Version Date: 2023-08-29
• Public Version Status: Update
• Public Device Record Key: c7b58f05-3a57-4c6a-85bd-8af96d7d8c5b
• Distribution End Date: 2018-10-31

Device Description

ST4, 2X2 MS CLOTH, LEAD CORDS

Device Characteristics

• Single Use: No
• 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: 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
GXY	Electrode, Cutaneous	Neurology	882.1320	2
LIH	Interferential Current Therapy	Neurology	882.5890	2
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	882.5890	2
IFP	Formalin, Neutral Buffered	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62411	Ultrasound coupling pad holder	A non-sterile device intended to hold an ultrasound coupling pad (not included) over the distal end of a noninvasive therapeutic ultrasound system applicator during treatment. It is typically a small attachment with a window designed to support the coupling pad in place while not obstructing transmission of ultrasound. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00852515007261	GS1

Customer Contacts

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