MJS System 3 Upgrade 850-822

GUDID 00718175004067

Biodex Multi-Joint-System 3 Rev.1 UpGrade

BIODEX MEDICAL SYSTEMS, INC.

Biomechanical function analysis system, force-testing, stationary

• Primary Device ID: 00718175004067
• NIH Device Record Key: deb0798e-a553-4ce1-bfca-fe95a41e838a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MJS System 3 Upgrade
• Version Model Number: 850-822
• Catalog Number: 850-822
• 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	00718175004067 [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: 2019-02-27
• Device Publish Date: 2018-08-10

On-Brand Devices [MJS System 3 Upgrade]

• 00718175004067: Biodex Multi-Joint-System 3 Rev.1 UpGrade
• 00718175004050: BIODEX SYSTEM 3 REMANUFACTURE