Home GUDID 00041167080450 Icy Hot SmartRelief
Primary DI 00041167080450
Brand Icy Hot SmartRelief
Company CHATTEM, INC.
Model SmartRelief 1.0 - Back/Hip Kit
Device description Over-The-Counter (OTC) Transcutaneous Electrical Nerve Stimulator (TENS) - Back & Hip
Published 2016-08-25
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 NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter NYN Stimulator, Electrical, Transcutaneous, For Arthritis
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter Neurology 2 NYN Stimulator, Electrical, Transcutaneous, For Arthritis Neurology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00041167080450 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 00041167080450 00041167080450 041167080450 0041167080450
GMDN Terms# Term, Definition table Term Definition Transcutaneous electrical stimulation electrode, single-use An electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation (EMS), cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a single-use device.
Regulatory Flags# DUNS number 003336013 Device count 1 Lot or batch true Serial number true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00041167080467 Icy Hot SmartRelief SmartRelief 1.0 - Back/Hip Refill 2016-08-25 00041167080474 Icy Hot SmartRelief SmartRelief 1.0 - Knee/Shoulder Kit 2016-08-25 00041167080498 Icy Hot SmartRelief SmartRelief 1.0 - Knee/Shoulder Refill 2016-08-25 00041167080818 Icy Hot SmartRelief SmartRelief 1.0 - Club Pack 2016-09-15
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