TENSRX NPPELE615

GUDID 00815991020353

Transcutaneous electrical stimulation electrode

Primary Device ID	00815991020353
NIH Device Record Key	f5f7b4b4-d89b-4dd9-986a-a74af77d45c5
Commercial Distribution Status	In Commercial Distribution
Brand Name	TENSRX
Version Model Number	ELE615
Catalog Number	NPPELE615
Company DUNS	066689993
Company Name	BOXOUT, LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00815991020353 [Primary]
GS1	10815991020350 [Package] Package: inner box [65 Units] In Commercial Distribution
GS1	20815991020357 [Package] Contains: 10815991020350 Package: Master Carton [8 Units] In Commercial Distribution

GXY	Electrode, Cutaneous

Steralize Prior To Use	false
Device Is Sterile	false

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