FDA.reportPublic FDA data

WELLBRACE

Primary DI
07798128673581
Brand
WELLBRACE
Company
PANTYMED S.A.
Model
1215-ANR U L
Device description
ANTI-SNORING SUPPORT
Published
2024-02-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FQLStocking, Medical Support (For General Medical Purposes)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQLStocking, Medical Support (For General Medical Purposes)General Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07798128673581PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07798128673581077981286735817798128673581

GMDN Terms#

Term, Definition table
TermDefinition
Limb/torso/head restraint, reusableA non-rigid device, typically a strap(s) or band(s) or garment-like, intended to be temporarily placed on or around one or more parts of a patient’s body (e.g., torso, limbs, head) to restrict movement, to facilitate patient positioning and stabilization during a medical procedure, and/or to prevent injury/hazards while potentially permitting limited movement. It is made of various materials (e.g., fabric, nylon, leather, or foam) and typically anchored to a fixture or furniture part (e.g., a bedrail, operating table). It is not intended for immobilization of specific joint. 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
08300496074489SOLIDEACALZIFICIO PINELLI SRLFQL2026-10-16
08300496074496SOLIDEACALZIFICIO PINELLI SRLFQL2026-10-16
08300496074502SOLIDEACALZIFICIO PINELLI SRLFQL2026-10-16
08300496074519SOLIDEACALZIFICIO PINELLI SRLFQL2026-10-16
08300496074526SOLIDEACALZIFICIO PINELLI SRLFQL2026-10-16
08300496074533SOLIDEACALZIFICIO PINELLI SRLFQL2026-10-16
08300496074540SOLIDEACALZIFICIO PINELLI SRLFQL2026-10-16
08300496074557SOLIDEACALZIFICIO PINELLI SRLFQL2026-10-16
08300496074564SOLIDEACALZIFICIO PINELLI SRLFQL2026-10-16
00674854000013SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000020SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000037SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000044SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000068SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000075SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000082SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000099SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000105SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000112SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000129SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000136SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000143SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000150SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000167SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000174SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000181SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000198SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000204SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000211SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000228SOFT SOCK ®Thuasne LLCFQL2018-12-31