Home GUDID 00310742098426
WellPatch(R) HEAT THERAPY PAIN RELIEF PATCH
Primary DI 00310742098426
Brand WellPatch(R) HEAT THERAPY PAIN RELIEF PATCH
Company MENTHOLATUM COMPANY, THE
Model 9842
Device description "WellPatch(R) HEAT THERAPY PAIN RELIEF PATCH.Drug Free.1 Large Patch.5"" x 4"" (13 x 10 cm) EACH."
Published 2020-02-07
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
OTC true
Single use true
Product Codes# Code, Name table Code Name IMD Pack, Hot Or Cold, Disposable
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class IMD Pack, Hot Or Cold, Disposable Physical Medicine 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00310742098433 Package GS1 4 In Commercial Distribution 00310742998429 Package GS1 120 In Commercial Distribution 00310742998436 Package GS1 24 In Commercial Distribution 00310742098426 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00310742098433 00310742098433 310742098433 0310742098433 00310742998429 00310742998429 310742998429 0310742998429 00310742998436 00310742998436 310742998436 0310742998436 00310742098426 00310742098426 310742098426 0310742098426
GMDN Terms# Term, Definition table Term Definition Musculoskeletal hot/cold therapy pack, single-use A non-powered device intended to be applied with or without pressure to the body surface (i.e., non-invasively) to provide heat and/or cold therapy for the skin and/or underlying tissues in the treatment of musculoskeletal pain and discomfort (e.g., from sports injuries or rheumatism). It consists of a compact envelope filled with a thermally-retentive material (e.g., silicate-based gel) that can be heated and/or cooled. It may be shaped/sized to fit a specific anatomy or include a strap; it is not intended to support the neck, nor is it designed to be dedicated to eye thermal therapy. This is a single-use device.
Regulatory Flags# DUNS number 002105757 Device count 1 Premarket exempt true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00310742015706 WellPatch(R) MIGRAINE & HEADACHE Cooling Patch, 4 Count 1570 2020-02-07 00310742011234 Mentholatum Kids Head Lice Removal Kit 1123 2021-07-01 00310742015904 Mentholatum(R) VaporDuo(TM) 1590 2020-02-07 00310742915907 Mentholatum(R) VaporDuo(TM) 1590 2020-02-07 00310742998429 WellPatch(R) HEAT THERAPY PAIN RELIEF PATCH 9842 2020-02-07
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