FDA.reportPublic FDA data

PROFIT

Primary DI
07798128671303
Brand
PROFIT
Company
PANTYMED S.A.
Model
1101-EM1 U S
Device description
ELASTIC WRIST SUPPORT - SIZE S
Published
2024-02-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IQIOrthosis, Limb Brace

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQIOrthosis, Limb BracePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07798128671303PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07798128671303077981286713037798128671303

GMDN Terms#

Term, Definition table
TermDefinition
Wrist orthosisA prefabricated (non-customized) externally applied orthopaedic appliance or apparatus designed to support, align, prevent, or correct deformities/injuries or to improve function of the wrist. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
971365986
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07798128671310PROFIT1101-EM1 U M2024-02-14
07798128671327PROFIT1101-EM1 U L2024-02-14
07798094541310WELLBRACE1101-6000 U U2024-01-05
07798094547930WELLBRACE1102-6020 U U2024-01-05
07798128673499WELLBRACE1101-M8 U S2024-01-05
07798128673505WELLBRACE1101-M8 U M2024-01-05
07798128673512WELLBRACE1101-M8 U L2024-01-05
07798094549392PROFIT1601-1313 U U2024-01-04
07798094549408PROFIT1601-1325 U U2024-01-04
07798094549415PROFIT1601-2425 U U2024-01-04
07798094540023WELLBRACE1601-AR U U2024-01-08
07798094540627WELLBRACE1204-610 U S2024-01-05
07798094540634WELLBRACE1204-610 U M2024-01-05
07798094540641WELLBRACE1204-610 U L2024-01-05
07798094540658WELLBRACE1204-610 U XL2024-01-05
07798094540665WELLBRACE1204-610 U 2XL2024-01-05
07798094540672WELLBRACE1204-611 U S2024-01-05
07798094540689WELLBRACE1204-611 U M2024-01-05
07798094540696WELLBRACE1204-611 U L2024-01-05
07798094540702WELLBRACE1204-611 U XL2024-01-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00636257220733MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220740MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220757MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220764MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220771MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220788MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220795MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220801MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220887MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220894MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220900MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220917MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220924MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220931MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220948MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220955MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220962MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220979MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220986MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220993MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257221006MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257221068MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257221075MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257221082MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00840536824288PediHipORTHOPEDIATRICS CORP.IQI2026-10-07
00840536824295PediHipORTHOPEDIATRICS CORP.IQI2026-10-07
00840536824301PediHipORTHOPEDIATRICS CORP.IQI2026-10-07
00840536824318PediHipORTHOPEDIATRICS CORP.IQI2026-10-07
00840536824325PediHipORTHOPEDIATRICS CORP.IQI2026-10-07
00840536824332PediHipORTHOPEDIATRICS CORP.IQI2026-10-07