DuraTENS 700000548

GUDID 30009336010227

Ref SS-3 Supplier PN: R50100C2WF-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 ID30009336010227
NIH Device Record Key717578c6-fbdd-442e-ae43-0519b2e8066e
Commercial Distribution StatusIn Commercial Distribution
Brand NameDuraTENS
Version Model Number700000548
Catalog Number700000548
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
GS100009336010226 [Unit of Use]
GS110009336010223 [Primary]
GS130009336010227 [Package]
Contains: 10009336010223
Package: Box [60 Units]
In Commercial Distribution
GS150009336010221 [Package]
Contains: 10009336010223
Package: Case/Master Carton [1800 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 [DuraTENS]

30009336010227Ref SS-3 Supplier PN: R50100C2WF-T Neurostimulation Electrode
30009336010210Ref SS-2 Supplier PN: S5050C2WF-T Neurostimulation Electrode
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