AccessGUDID - DEVICE: WINNER EVO PACKAGE (00852515007636)

GUDID

Device Identifier (DI) Information

Brand Name: WINNER EVO PACKAGE
Version or Model: 410-010-220
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: COMPASS HEALTH BRANDS CORP.

Primary DI Number: 00852515007636
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 827221698 *Terms of Use

Device Description: CM2 220, 5CM, LASER MODULE, 2X2 MS CLOTH, LEAD CORDS, 5CM GELSHOTS & ADAPTOR

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false
17908	Physical therapy ultrasound/neuromuscular stimulation system	An assembly of devices that includes a neuromuscular electrical stimulator as an integral part of a therapeutic ultrasound system intended for the simultaneous delivery of ultrasound and electrical energies for physical therapy, typically to help prevent scar tissue formation in healing tissues and to help reduce muscle spasms and pain; it may in addition be capable of delivering either energy alone. The system is designed to produce a rhythmic contraction/release of injured muscles to promote the removal of metabolic by-products while applying ultrasound treatments.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MUI	Media,Coupling,Ultrasound
GXY	Electrode, Cutaneous
ILY	Lamp, Infrared, Therapeutic Heating
IMG	Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
IMI	Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
IPF	Stimulator, Muscle, Powered
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief
LIH	Interferential Current Therapy

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2b7c1a3e-8421-4736-bd11-de516fe27e1b
Public Version Date: August 24, 2023
Public Version Number: 6
DI Record Publish Date: November 21, 2016