BALANCE SD 950-444

GUDID 00718175000052

Balance System SD, 100 VAC

BIODEX MEDICAL SYSTEMS, INC.

Posturography system Posturography system

• Primary Device ID: 00718175000052
• NIH Device Record Key: 2bc00e11-d1fa-4231-9789-146eb0d34657
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BALANCE SD
• Version Model Number: 950-444
• Catalog Number: 950-444
• 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	00718175000052 [Primary]

FDA Product Code

• KHX: Platform, Force-Measuring

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: 2018-07-31
• Device Publish Date: 2018-06-30

On-Brand Devices [BALANCE SD]

• 00718175000052: Balance System SD, 100 VAC
• 00718175000045: Balance System SD, 230 VAC
• 00718175000038: Balance System SD, 115 VAC