L300 Go System L300 Go System, Right Thigh Stand-Alone

GUDID 00815962020207

Gait-enhancement electrical stimulation system, external

Primary Device ID	00815962020207
NIH Device Record Key	e109fe2f-33f6-4301-9da9-f2a8573a6240
Commercial Distribution Status	In Commercial Distribution
Brand Name	L300 Go System
Version Model Number	L4T-5000
Catalog Number	L300 Go System, Right Thigh Stand-Alone
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	true
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
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

Storage Environment Temperature	Between -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -25 Degrees Celsius and 55 Degrees Celsius

Device Issuing Agency	Device ID
GS1	00815962020207 [Primary]

IPF	Stimulator, muscle, powered

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