System 4 Quick Set 840-000

GUDID 00718175004203

System 4 Quick Set

BIODEX MEDICAL SYSTEMS, INC.

Back/leg/chest dynamometer Back/leg/chest dynamometer Biomechanical function analysis system, force-testing, stationary Biomechanical function analysis system, force-testing, stationary Biomechanical function analysis system, force-testing, stationary Biomechanical function analysis system, force-testing, stationary Biomechanical function analysis system, force-testing, stationary Biomechanical function analysis system, force-testing, stationary Biomechanical function analysis system, force-testing, stationary Biomechanical function analysis system, force-testing, stationary Biomechanical function analysis system, force-testing, stationary Biomechanical function analysis system, force-testing, stationary Biomechanical function analysis system, force-testing, stationary Biomechanical function analysis system, force-testing, stationary Biomechanical function analysis system, force-testing, stationary Biomechanical function analysis system, force-testing, stationary Biomechanical function analysis system, force-testing, stationary Biomechanical function analysis system, force-testing, stationary Biomechanical function analysis system, force-testing, stationary

• Primary Device ID: 00718175004203
• NIH Device Record Key: 889c599c-9d38-4063-b2f2-e01bf21be64e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: System 4 Quick Set
• Version Model Number: 840-000
• Catalog Number: 840-000
• 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	00718175004203 [Primary]

FDA Product Code

• IKK: System, Isokinetic Testing And Evaluation

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: 2017-12-18

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