FDA.reportPublic FDA data

WELLBRACE

Primary DI
07798094548791
Brand
WELLBRACE
Company
PANTYMED S.A.
Model
1301-401 U S
Device description
ORTHOPEDIC METATARSAL BAND - SIZE S
Published
2024-02-14
Public version status
New
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
07798094548791PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07798094548791077980945487917798094548791

GMDN Terms#

Term, Definition table
TermDefinition
Foot orthosisA device designed to encompass the whole or part of the foot, or designed as a plantar insert, and intended to provide rigid or semi-rigid correction of the foot for persons with orthopaedic deformities/injuries of the feet; it may also be intended to offload and redistribute foot pressures that affect pedal circulation to improve blood flow and help heal diabetic foot ulcers or postsurgical wounds. It is typically made of metal, synthetic, and/or textile materials and may include customizable plantar inserts. This is a single-patient use device that can be reapplied to the patient during the treatment period (reusable) before being discarded.

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
07798128671303PROFIT1101-EM1 U S2024-02-14
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

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
00636257221358MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221365MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221372MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221389MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221396MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221402MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221419MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221426MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221433MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221440MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221457MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221464MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221471MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221488MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221495MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221501MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221563MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221570MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221587MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221594MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221600MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221617MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221624MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221631MEDIMEDI MANUFACTURING, INC.IQI2026-07-20