L300 Go System

GUDID 00815962020436

Transcutaneous electrical stimulation electrode

Primary Device ID	00815962020436
NIH Device Record Key	f30115f8-8e78-4242-973d-dc28e21c7ea4
Commercial Distribution Status	In Commercial Distribution
Brand Name	L300 Go System
Version Model Number	SCE-1100
Company DUNS	182287727
Company Name	BIONESS INC.
Device Count	1
DM Exempt	true
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	false
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	00815962020436 [Primary]

GZI	STIMULATOR, NEUROMUSCULAR, EXTERNAL FUNCTIONAL

Steralize Prior To Use	false
Device Is Sterile	false

00815962020207	10/17/2019
00815962020504	Small Quick Fit Electrodes - B
00815962020498	Small Quick Fit Electrodes - A
00815962020481	Small Hydrogel Electrodes, 36mm
00815962020474	Small Round Cloth Electrodes, 36mm
00815962020467	Round Cloth Electrodes, 45mm
00815962020450	Quick Fit Electrode, Left
00815962020443	Quick Fit Electrode, Right
00815962020436	Steering Cloth Electrode, Left
00815962020429	Steering Cloth Electrode, Right
00815962020412	Thigh Cloth Electrode Set, Offset
00815962020405	Thigh Cloth Electrode Set, centered