NESS L300-Plus System 501-00127-01

GUDID 07290110483036

L300 Plus US Upgrade System Kit, Right (regular)

BIONESS INC.

Gait-enhancement electrical stimulation system, external
Primary Device ID07290110483036
NIH Device Record Keye7f8f5cb-bafb-4a6e-88cd-e6ff610342b5
Commercial Distribution Discontinuation2017-09-30
Commercial Distribution StatusNot in Commercial Distribution
Brand NameNESS L300-Plus System
Version Model NumberL3P-5100
Catalog Number501-00127-01
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
Phone+97297907100
Emailinfo@bioness.co.il
Phone+97297907100
Emailinfo@bioness.co.il
Phone+97297907100
Emailinfo@bioness.co.il
Phone+97297907100
Emailinfo@bioness.co.il
Phone+97297907100
Emailinfo@bioness.co.il
Phone+97297907100
Emailinfo@bioness.co.il
Phone+97297907100
Emailinfo@bioness.co.il
Phone+97297907100
Emailinfo@bioness.co.il
Phone+97297907100
Emailinfo@bioness.co.il

Operating and Storage Conditions

Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107290110483036 [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-Plus System]

07290110483043L300 Plus US Clinician's Upgrade Kit
07290110483036L300 Plus US Upgrade System Kit, Right (regular)
07290110483029L300 Plus US Upgrade System Kit, Left (regular)
07290110483012L300 Plus US System Kit, Right (regular)
07290110483005L300 Plus US System Kit, Left (regular)

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