Slendertone Arm Toner Muscle Training System Gel P

GUDID 15099058718007

BIO-MEDICAL RESEARCH LIMITED

Transcutaneous electrical stimulation electrode
Primary Device ID15099058718007
NIH Device Record Key5e851892-5e77-4d70-8f94-bd035d54aeae
Commercial Distribution StatusIn Commercial Distribution
Brand NameSlendertone Arm Toner Muscle Training System Gel P
Version Model Number718
Company DUNS987904356
Company NameBIO-MEDICAL RESEARCH LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS115099058718007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXYElectrode, Cutaneous

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

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