FDA.reportPublic FDA data

WELLBRACE

Primary DI
07798094548029
Brand
WELLBRACE
Company
PANTYMED S.A.
Model
1201-4519 U XL
Device description
PHILADELPHIA NECKLACE - SIZE XL
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
IQKOrthosis, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQKOrthosis, CervicalPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07798094548029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07798094548029077980945480297798094548029

GMDN Terms#

Term, Definition table
TermDefinition
Cervical spine collar, reusableA prefabricated (non-customized) padded device that is worn around the neck and intended to support or immobilize the cervical spine to treat deformities, fractures, sprains, or strains (often to treat whiplash resulting from an automobile accident). This device will provide support to the head while limiting movement of the cervical vertebrae. It is available in a variety of sizes. 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
00850071315226TrendOrthofix US LLCIQK2026-04-25
00850071315233TrendOrthofix US LLCIQK2026-04-14
00749756879699DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879705DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879712DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879729DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879736DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879750DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879767DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879774DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879804DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879811DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879828DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879835DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879989DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879996DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756880008DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756880084DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756880091DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756880107DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756887601DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756887618DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756887625DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756887632DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756887649DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756887656DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756887687DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756887694DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756887700DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756887717DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02