NxSTEP 945-480

GUDID 00718175004807

NxSTEP Unweighing System

BIODEX MEDICAL SYSTEMS, INC.

Mobile gait rehabilitation system, harness-support

• Primary Device ID: 00718175004807
• NIH Device Record Key: ab3f9ba9-51d8-4769-9e26-07c3724b3b38
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NxSTEP
• Version Model Number: 945-480
• Catalog Number: 945-480
• Company DUNS: 043833813
• Company Name: BIODEX MEDICAL SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00718175004807 [Primary]

FDA Product Code

• ITJ: Walker, Mechanical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-23
• Device Publish Date: 2019-05-15

On-Brand Devices [NxSTEP]

• 00718175004852: NxSTEP Unweighing System, 115VAC
• 00718175004845: NxSTEP Unweighing System, without Harness
• 00718175004807: NxSTEP Unweighing System