BioTens 700000543

GUDID 30009336010173

Ref BF-2 Supplier PN: S5050C2WC-T Neurostimulation Electrode

GRAPHIC CONTROLS ACQUISITION CORP

Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable
Primary Device ID30009336010173
NIH Device Record Keyc7fd8f4e-5c4f-4f19-88ea-0d4962ca8661
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioTens
Version Model Number700000543
Catalog Number700000543
Company DUNS002111896
Company NameGRAPHIC CONTROLS ACQUISITION CORP
Device Count4
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-853-7500
EmailHS.Info@NisshaMedical.com
Phone800-853-7500
EmailHS.Info@NisshaMedical.com
Phone800-853-7500
EmailHS.Info@NisshaMedical.com
Phone800-853-7500
EmailHS.Info@NisshaMedical.com
Phone800-853-7500
EmailHS.Info@NisshaMedical.com
Phone800-853-7500
EmailHS.Info@NisshaMedical.com
Phone800-853-7500
EmailHS.Info@NisshaMedical.com
Phone800-853-7500
EmailHS.Info@NisshaMedical.com
Phone800-853-7500
EmailHS.Info@NisshaMedical.com
Phone800-853-7500
EmailHS.Info@NisshaMedical.com
Phone800-853-7500
EmailHS.Info@NisshaMedical.com
Phone800-853-7500
EmailHS.Info@NisshaMedical.com
Phone800-853-7500
EmailHS.Info@NisshaMedical.com
Phone800-853-7500
EmailHS.Info@NisshaMedical.com
Phone800-853-7500
EmailHS.Info@NisshaMedical.com
Phone800-853-7500
EmailHS.Info@NisshaMedical.com
Phone800-853-7500
EmailHS.Info@NisshaMedical.com
Phone800-853-7500
EmailHS.Info@NisshaMedical.com
Phone800-853-7500
EmailHS.Info@NisshaMedical.com
Phone800-853-7500
EmailHS.Info@NisshaMedical.com
Phone800-853-7500
EmailHS.Info@NisshaMedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100009336010172 [Unit of Use]
GS110009336010179 [Primary]
GS130009336010173 [Package]
Contains: 10009336010179
Package: Box [80 Units]
In Commercial Distribution
GS150009336010177 [Package]
Contains: 10009336010179
Package: Case/Master Carton [2400 Units]
In Commercial Distribution

FDA Product Code

GXYElectrode, Cutaneous

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-04-19
Device Publish Date2022-04-11

On-Brand Devices [BioTens]

30009336010203Ref BF-8 Supplier PN: O5090C2WC-T Neurostimulation Electrode
30009336010197Ref BF-5 Supplier PN: C50C2WC-T Neurostimulation Electrode
30009336010180Ref BF-3 Supplier PN: R50100C2WC-T Neurostimulation Electrode
30009336010173Ref BF-2 Supplier PN: S5050C2WC-T Neurostimulation Electrode

Trademark Results [BioTens]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BIOTENS
BIOTENS
77489051 not registered Dead/Abandoned
J.F. Fong, Inc
2008-06-02
BIOTENS
BIOTENS
77083838 not registered Dead/Abandoned
Alex Fong
2007-01-16

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.