FDA.reportPublic FDA data

WINNER EVO PACKAGE

Primary DI
00852515007322
Brand
WINNER EVO PACKAGE
Company
Drive Devilbiss Healthcare
Model
410-012
Device description
CM4, THERAPY HAMMER, AUTOSOUND, LASER MODULE, 1 CASE OF 2X2 MS CLOTH, LEAD CORDS, 5CM GELSHOTS & ADAPTORS
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852515007322PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852515007322008525150073228525150073220852515007322

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
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
00023601005168CAREX HEALTH BRANDSFGA51600 GRN2022-12-20
00023601005175CAREX HEALTH BRANDSFGA51700 BRNZ2022-12-20
00023601005182CAREX HEALTH BRANDSFGA51800 GRAY2022-12-20
00023601007117CAREX HEALTH BRANDSFGA71100 00002023-03-15
00023601007179CAREX HEALTH BRANDSFGA71700 00002023-03-15
00023601007186CAREX HEALTH BRANDSFGA71800 00002023-03-15
00023601007193CAREX HEALTH BRANDSFGA71900 00002023-03-15
00023601012210Carex Health BrandsFGA22100 00002022-12-09
00023601012227CAREX HEALTH BRANDSFGA22200 00002022-12-12
00023601012234CAREX HEALTH BRANDSFGA22300 00002022-12-12
00023601012302CAREX HEALTH BRANDSFGA23000 00002022-12-12
00023601012319CAREX HEALTH BRANDSFGA23177 00002022-12-12
00023601012333CAREX HEALTH BRANDSFGA23300 00002022-12-12
00023601013330CAREX HEALTH BRANDSFGA33300 00002022-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08057971594795Remote Wave ElectrodeBIONIT LABS SRLGXY2026-03-20
08057971594801Remote Wave ElectrodeBIONIT LABS SRLGXY2026-03-20
08057971594818Remote Wave ElectrodeBIONIT LABS SRLGXY2026-03-20
B195XC813waveguardeemagine Medical Imaging Solutions GmbHGXY2026-03-19
03615220004355Neuronaute IceCap 2 SmallBIOSERENITY MEDICAL DEVICES GROUPGXY2026-03-17
00860008546005Nexalin ADINEXALIN TECHNOLOGYGXY2026-03-16
09342451004772Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-03
00850080988121AUVONUAN HEALTHCARE LIMITEDGXY2026-03-02
09342451003904Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451003980Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451003997Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004000Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004017Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004024Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004031Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004314Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004611Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004628Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004635Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004642Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004659Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004673Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004680Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004697Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004703Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004710Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004727Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004734Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004741Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004758Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02