Vector Elite

GUDID 00815962020269

Vector Gait and Safety System

BIONESS INC.

Gait rehabilitation system harness

• Primary Device ID: 00815962020269
• NIH Device Record Key: 7820fdeb-f6ae-4c68-b122-8f790ca948f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vector Elite
• Version Model Number: VEC-1000
• Company DUNS: 182287727
• Company Name: BIONESS INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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

Customer Support Contacts

• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815962020269 [Primary]

FDA Product Code

• BXB: EXERCISER, 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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-12-07

On-Brand Devices [Vector Elite]

• 00815962020276: Vector Trolley Assembly, Elite Model
• 00815962020269: Vector Gait and Safety System