FDA.reportPublic FDA data

WELLBRACE

Primary DI
07798094540313
Brand
WELLBRACE
Company
PANTYMED S.A.
Model
1205-2800T U S
Device description
SOFTY PLUS TUBULAR GIRDLE 28 CM - SIZE S
Published
2024-02-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KTDOrthosis, Abdominal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTDOrthosis, AbdominalPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07798094540313PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07798094540313077980945403137798094540313

GMDN Terms#

Term, Definition table
TermDefinition
Abdominal binder, reusableA strip, roll or tube of fabric or polymer material intended to be applied to the abdomen to support relaxed abdominal walls (e.g., after surgery, during pregnancy) or to provide support for another device (e.g., dressing, ultrasound transducer, percutaneous lead). 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
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
08809766910156SpinamicValue&TrustKTD2026-03-18
08809766910163SpinamicValue&TrustKTD2026-03-18
08809766910170SpinamicValue&TrustKTD2026-03-18
08809766910187SpinamicValue&TrustKTD2026-03-18
08809766910194SpinamicValue&TrustKTD2026-03-18
08809766910255SpinamicValue&TrustKTD2026-03-18
08809766910262SpinamicValue&TrustKTD2026-03-18
08809766910279SpinamicValue&TrustKTD2026-03-18
08809766910286SpinamicValue&TrustKTD2026-03-18
08809766910293SpinamicValue&TrustKTD2026-03-18
08809766910309SpinamicValue&TrustKTD2026-03-18
08809766910316SpinamicValue&TrustKTD2026-03-18
08809766910323SpinamicValue&TrustKTD2026-03-18
04823097716618"TM ""Rehabilitimed"" S-3M XXXL Comfort"REABILITIMED TOVKTD2025-05-04
04823097716625"TM ""Rehabilitimed"" S-3 XXXL Comfort"REABILITIMED TOVKTD2025-05-04
04823097716632"TM ""Rehabilitimed"" S-3M XXL Comfort"REABILITIMED TOVKTD2025-05-04
04823097716649"TM ""Rehabilitimed"" S-4M L Comfort"REABILITIMED TOVKTD2025-05-04
04823097716656"TM ""Rehabilitimed"" S-3 L Comfort"REABILITIMED TOVKTD2025-05-04
04823097716663"TM ""Rehabilitimed"" S-3 XL Comfort"REABILITIMED TOVKTD2025-05-04
04823097716670"TM ""Rehabilitimed"" S-4 XXL Comfort"REABILITIMED TOVKTD2025-05-04
04823097716687"TM ""Rehabilitimed"" S-4 XL Comfort"REABILITIMED TOVKTD2025-05-04
04823097716694"TM ""Rehabilitimed"" S-4 M Comfort"REABILITIMED TOVKTD2025-05-04
04823097716700"TM ""Rehabilitimed"" S-4 L Comfort"REABILITIMED TOVKTD2025-05-04
04823097716717"TM ""Rehabilitimed"" S-4 XXXL Comfort"REABILITIMED TOVKTD2025-05-04
04823097716724"TM ""Rehabilitimed"" S-3 M Comfort"REABILITIMED TOVKTD2025-05-04
04823097716731"TM ""Rehabilitimed"" S-4M M Comfort"REABILITIMED TOVKTD2025-05-04
04823097716748"TM ""Rehabilitimed"" S-3M L Comfort"REABILITIMED TOVKTD2025-05-04
04823097716755"TM ""Rehabilitimed"" S-4M XXXL Comfort"REABILITIMED TOVKTD2025-05-04
04823097716762"TM ""Rehabilitimed"" S-3M XL Comfort"REABILITIMED TOVKTD2025-05-04
04823097716779"TM ""Rehabilitimed"" S-4M XXL Comfort"REABILITIMED TOVKTD2025-05-04