TENSRX 615

GUDID 20815991020340

TENSRX SELF ADHESIVE ELECTRODE 2X2, FABRIC BACKING, 500/CASE

BOXOUT, LLC

Transcutaneous electrical stimulation electrode
Primary Device ID20815991020340
NIH Device Record Keyf6bc6d12-c463-4dc3-9b39-4b43f96dd38e
Commercial Distribution StatusIn Commercial Distribution
Brand NameTENSRX
Version Model NumberNPPELE615
Catalog Number615
Company DUNS066689993
Company NameBOXOUT, LLC
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone866-528-2152
Emailinfo@bodysportproducts.com
Phone866-528-2152
Emailinfo@bodysportproducts.com
Phone866-528-2152
Emailinfo@bodysportproducts.com
Phone866-528-2152
Emailinfo@bodysportproducts.com
Phone866-528-2152
Emailinfo@bodysportproducts.com
Phone866-528-2152
Emailinfo@bodysportproducts.com
Phone866-528-2152
Emailinfo@bodysportproducts.com
Phone866-528-2152
Emailinfo@bodysportproducts.com
Phone866-528-2152
Emailinfo@bodysportproducts.com
Phone866-528-2152
Emailinfo@bodysportproducts.com
Phone866-528-2152
Emailinfo@bodysportproducts.com
Phone866-528-2152
Emailinfo@bodysportproducts.com
Phone866-528-2152
Emailinfo@bodysportproducts.com
Phone866-528-2152
Emailinfo@bodysportproducts.com
Phone866-528-2152
Emailinfo@bodysportproducts.com
Phone866-528-2152
Emailinfo@bodysportproducts.com
Phone866-528-2152
Emailinfo@bodysportproducts.com
Phone866-528-2152
Emailinfo@bodysportproducts.com
Phone866-528-2152
Emailinfo@bodysportproducts.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100815991020346 [Primary]
GS110815991020343 [Package]
Contains: 00815991020346
Package: Inner box [65 Units]
In Commercial Distribution
GS120815991020340 [Package]
Contains: 10815991020343
Package: Master Carton [8 Units]
In Commercial Distribution

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 Date2020-02-27
Device Publish Date2016-09-05

On-Brand Devices [TENSRX]

00815991020353TENSRX SELF ADHESIVE ELECTRODE 2X2, FABRIC BACKING, 520/CASE
20815991020340TENSRX SELF ADHESIVE ELECTRODE 2X2, FABRIC BACKING, 500/CASE

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