Disposable Passive Sphere

GUDID 04719878713207

Taiwan Main Orthopaedic Biotechnology Co., Ltd.

Surgical planning/navigation-enhancement system

• Primary Device ID: 04719878713207
• NIH Device Record Key: 3853bcb5-31ab-4f40-b9cd-c6568edc9c83
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Passive Sphere
• Version Model Number: CDS-DPS-04
• Company DUNS: 658875222
• Company Name: Taiwan Main Orthopaedic Biotechnology Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719878713207 [Primary]

FDA Product Code

• SBF: Orthopedic Augmented Reality

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-10
• Device Publish Date: 2024-12-02

On-Brand Devices [Disposable Passive Sphere]

• 04719878713207: CDS-DPS-04
• 04719878713016: CDS-DPS-00