OPSB Sensor

GUDID 00860013109806

OPSB Sensor

Boston Brace International, Inc.

Wireless patient monitor/sensor reporting software, layperson-use

• Primary Device ID: 00860013109806
• NIH Device Record Key: cd9e7370-b7e6-4175-91ec-15bf940ce3e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPSB Sensor
• Version Model Number: SENSOR-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	00860013109806 [Primary]

FDA Product Code

• NHF: Monitor, Orthotic/Prosthetic

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.

• 00860014460807 - Boston Body Jacket, Single Opening: 2025-08-13
• 00860014460814 - Boston Body Jacket, Bivalve Opening: 2025-08-13
• 00860014460821 - Boston Overlap Brace (BOB): 2025-08-13
• 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