NESS L300-Plus System 501-00126-01

GUDID 07290110483029

L300 Plus US Upgrade System Kit, Left (regular)

BIONESS INC.

Gait-enhancement electrical stimulation system, external

• Primary Device ID: 07290110483029
• NIH Device Record Key: c9e22560-b1b8-42aa-9d2f-5d0a02d5599b
• Commercial Distribution Discontinuation: 2017-09-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: NESS L300-Plus System
• Version Model Number: L3P-5101
• Catalog Number: 501-00126-01
• 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

Customer Support Contacts

• Phone: +97297907100
• Email: info@bioness.co.il
• Phone: +97297907100
• Email: info@bioness.co.il
• Phone: +97297907100
• Email: info@bioness.co.il
• Phone: +97297907100
• Email: info@bioness.co.il
• Phone: +97297907100
• Email: info@bioness.co.il
• Phone: +97297907100
• Email: info@bioness.co.il
• Phone: +97297907100
• Email: info@bioness.co.il
• Phone: +97297907100
• Email: info@bioness.co.il
• Phone: +97297907100
• Email: info@bioness.co.il
• Phone: +97297907100
• Email: info@bioness.co.il

Operating and Storage Conditions

• Storage Environment Temperature: Between -25 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290110483029 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103343

FDA Product Code

• IPF: Stimulator, muscle, powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-08
• Device Publish Date: 2017-02-02

On-Brand Devices [NESS L300-Plus System]

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