OPSB Sensor Web Portal

GUDID 00860013109820

Boston Brace International, Inc.

Wireless patient monitor/sensor reporting software, layperson-use

• Primary Device ID: 00860013109820
• NIH Device Record Key: 463f0f66-db8a-4091-be4a-4c79fa267c1c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPSB Sensor Web Portal
• Version Model Number: SENSOR-WP-V1
• Company DUNS: 801816158
• Company Name: Boston Brace International, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860013109820 [Primary]

FDA Product Code

• OUG: Medical Device Data System

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: 2025-03-03
• Device Publish Date: 2025-02-21

Devices Manufactured by Boston Brace International, Inc.

• 00860010708194 - Lower Limb Orthotics: 2025-04-21
• 00860013109844 - Lower Limb Orthotics: 2025-04-21
• 00860013109851 - Lower Limb Orthotics: 2025-04-21
• 00860013109868 - Lower Limb Orthotics: 2025-04-21
• 00860013109875 - Lower Limb Orthotics: 2025-04-21
• 00860013109882 - Lower Limb Orthotics: 2025-04-21
• 00860013109899 - Lower Limb Orthotics: 2025-04-21
• 00860013109806 - OPSB Sensor: 2025-03-03 OPSB Sensor