NESS L300 Foot Drop System 501-00161-01

GUDID 07290110483074

Regular L300 Clinician's Kit US

BIONESS INC.

Gait-enhancement electrical stimulation system, external
Primary Device ID07290110483074
NIH Device Record Key255a6556-f3fa-4ad2-80ab-b404dfd1b51c
Commercial Distribution Discontinuation2017-09-30
Commercial Distribution StatusNot in Commercial Distribution
Brand NameNESS L300 Foot Drop System
Version Model NumberLG3-4000
Catalog Number501-00161-01
Company DUNS182287727
Company NameBIONESS INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+97297907100
Emailinfo@bioness.co.il

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107290110483074 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IPFStimulator, muscle, powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-08
Device Publish Date2017-02-02

On-Brand Devices [NESS L300 Foot Drop System]

07290110483098Small L300 System Kit, Right US
07290110483081Small L300 System Kit, Left US
07290110483074Regular L300 Clinician's Kit US
07290110483067Regular L300 System Kit, Right US
07290110483050Regular L300 System Kit, Left US

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