FDA.reportPublic FDA data

WINNER EVO PACKAGE

Primary DI
00852515007391
Brand
WINNER EVO PACKAGE
Company
Compass Richmar, LLC
Model
410-012-220
Device description
CM4 220, 5CM, LASER MODULE, 2X2 MS FOAM, LEAD CORDS, 5CM GELSHOTS & ADAPTOR
Published
2016-11-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
MUIMedia,Coupling,Ultrasound

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUIMedia, Coupling, UltrasoundRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852515007391PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852515007391008525150073918525150073910852515007391

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous electrical stimulation electrodeA non-sterile 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, 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 single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-888-549-4945customerservice@richmarweb.com
800-376-7263customerservice@compasshealthbrands.com

Regulatory Flags#

DUNS number
080930531
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10853904006046BodyMed Iontophoresis Electrode KitSmall, Box of 122016-05-02
10853904006053BodyMed Iontophoresis Electrode KitMedium, Box of 122016-05-02
10853904006060BodyMed Iontophoresis Electrode KitLarge, Box of 122016-05-02
10853904006077BodyMed Iontophoresis Electrode KitButterfly, Box of 122016-05-02
10850958007159GelShotGSA2CH12016-11-23
10853904006398GelShotGAS5CH22016-11-23
10850689007312STICK-E-PADS203-6782016-11-18
10850689007329STICK-E-PADS203-6792016-11-18
10850689007336STICK-E-PADS203-6742016-11-18
10850689007343STICK-E-PADS203-6752016-11-18
10850689007350STICK-E-PADS203-6732016-11-18
10850689007367STICK-E-PADS203-6722016-11-18
10850689007374STICK-E-PADS203-6802016-11-18
10850689007381STICK-E-PADS203-6812016-11-18
10850689007398STICK-E-PADS203-6762016-11-18
10850689007404STICK-E-PADS203-6772016-11-18
10850689007428ValueStim202-6752016-11-18
10850689007442ValueStim202-6762016-11-18
10850689007466Adhesive Electrodes202-4542016-11-18
10850689007473Adhesive Electrodes202-4552016-11-18

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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30665973032659DukalDukal LLCMUI2026-01-12
30665973032666DukalDukal LLCMUI2026-01-12
30815112021406E-Z-GEL UltraSound GelBracco Diagnostics Inc.MUI2025-05-16
30815112021413E-Z-SCAN Low Viscosity UltraSound GelBracco Diagnostics Inc.MUI2025-05-16
30815112021420E-Z-SCAN Low Viscosity UltraSound GelBracco Diagnostics Inc.MUI2025-05-16
30815112021437E-Z-GEL UltraSound GelBracco Diagnostics Inc.MUI2025-05-16
20888277629841MEDLINEMEDLINE INDUSTRIES, INC.MUI2025-01-09
00850030915207RichmarSouth Dakota Partners Inc.MUI2023-08-02
10848340014854Asonic GelADVANCE MEDICAL DESIGNS, INC.MUI2023-06-13
40080196306238MedlineMEDLINE INDUSTRIES, INC.MUI2023-01-04
00810113688473ManaMed IncManamed, Inc.MUI2022-12-31
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10851809002361EcoVue HVHR PHARMACEUTICALS INC.MUI2020-09-21
20851809002375EcoVue HVHR PHARMACEUTICALS INC.MUI2020-09-21
M752HCT984915Stradis Medical, LLC.STRADIS MEDICAL LLCMUI2020-06-08
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