FDA.reportPublic FDA data

WINNER EVO PACKAGE

Primary DI
00852515007209
Brand
WINNER EVO PACKAGE
Company
Drive Devilbiss Healthcare
Model
410-016-220
Device description
ST4 220, 2X2 MS CLOTH, LASER MODULE, LEAD CORDS
Published
2016-11-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous
GZJStimulator, Nerve, Transcutaneous, For Pain Relief
IFPFormalin, Neutral Buffered
ILYLamp, Infrared, Therapeutic Heating
LIHInterferential Current Therapy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2
GZJStimulator, Nerve, Transcutaneous, For Pain ReliefNeurology2
IFPFormalin, Neutral BufferedPathology1
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2
LIHInterferential Current TherapyNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852515007209PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852515007209008525150072098525150072090852515007209

GMDN Terms#

Term, Definition table
TermDefinition
Coupling gel disk holderA non-sterile device intended to hold a coupling gel disk (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 gel disk in place while not obstructing transmission of ultrasound. This is a reusable device.

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
867673159
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00023601061102Carex Health BrandsFGR11000 00002016-10-07
00092237614419Roscoe MedicalHUM-ROS62018-12-19
50050428250391DRIVEMEDICAL7417372019-06-21
00311917192352Walgreens9847282019-06-21
00822383989815DRIVEMEDICAL146-RTLPC23201-M2019-06-21
00822383989839DRIVEMEDICAL146-RTLPC23201-F2019-06-21
00822383246420DriveRTLPC23201-F2017-05-19
00822383037127Silver SportBIN-SSP316DDA-SF2026-06-22
00822383037134Silver SportBIN-SSP218DDA-SF2026-06-22
00822383037141Silver SportBIN-SSP220DDA-SF2026-06-22
00822383037158Cruiser 3 16"BIN-K316ADDA-SF2026-06-22
00822383037165Cruiser 3 18"BIN-K318ADDA-SF2026-06-22
00822383037172Cruiser 3 20"BIN-K320ADDA-SF2026-06-22
00194346283439EquateEQKW5002026-06-10
10092237600105Roscoe MedicalEP4070WCD2016-10-18
90002360125501AccuReliefACRL-55002016-10-12
00009223761699Reliable MedicalEF2020BC2-TU2018-06-13
00009223761941EswallowESW-90502016-12-31
00023601005144CAREX HEALTH BRANDSFGA51400 00002022-12-20
00023601005151CAREX HEALTH BRANDSFGA51500 BLUE2022-12-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00382830063821NatusXLTEKGXY2026-10-15
00382830063838NatusXLTEKGXY2026-10-15
00382830063845NatusXLTEKGXY2026-10-15
00382830063852NatusXLTEKGXY2026-10-15
00382830063869NatusXLTEKGXY2026-10-15
00382830063876NatusXLTEKGXY2026-10-15
00382830063883NatusXLTEKGXY2026-10-15
00382830063890NatusXLTEKGXY2026-10-15
00382830063906NatusXLTEKGXY2026-10-15
00382830063913NatusXLTEKGXY2026-10-15
00382830063920NatusXLTEKGXY2026-10-15
00382830063937NatusXLTEKGXY2026-10-15
07090072490000FlexBeamRecharge Health ASILY2026-10-15
10849832018619Leica BiosystemsLeica Biosystems Richmond, Inc.IFP2026-10-13
10849832020360Leica BiosystemsLeica Biosystems Richmond, Inc.IFP2026-10-13
10849832022968Leica BiosystemsLeica Biosystems Richmond, Inc.IFP2026-10-13
10849832024122Leica BiosystemsLeica Biosystems Richmond, Inc.IFP2026-10-13
10849832024153Leica BiosystemsLeica Biosystems Richmond, Inc.IFP2026-10-13
10849832024306Leica BiosystemsLeica Biosystems Richmond, Inc.IFP2026-10-13
10849832024368Leica BiosystemsLeica Biosystems Richmond, Inc.IFP2026-10-13
10849832026904Leica BiosystemsLeica Biosystems Richmond, Inc.IFP2026-10-13
20849832020343Leica BiosystemsLeica Biosystems Richmond, Inc.IFP2026-10-13
20849832020350Leica BiosystemsLeica Biosystems Richmond, Inc.IFP2026-10-13
20849832020695Leica BiosystemsLeica Biosystems Richmond, Inc.IFP2026-10-13
20849832023092Leica BiosystemsLeica Biosystems Richmond, Inc.IFP2026-10-13
20849832024105Leica BiosystemsLeica Biosystems Richmond, Inc.IFP2026-10-13
20849832024112Leica BiosystemsLeica Biosystems Richmond, Inc.IFP2026-10-13
20849832024396Leica BiosystemsLeica Biosystems Richmond, Inc.IFP2026-10-13
20849832025676Leica BiosystemsLeica Biosystems Richmond, Inc.IFP2026-10-13
06971712725922DOMASHong Qiangxing (Shen Zhen) Electronics LimitedGZJ2026-10-13