Boston Body Jacket, Bivalve Opening Boston Body Jacket, Bivalve Opening

GUDID 00860014460814

Boston Brace International, Inc.

Multiple spinal region orthosis

• Primary Device ID: 00860014460814
• NIH Device Record Key: 0903eeb6-170f-4ee5-a9c1-4b4b8770663c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Boston Body Jacket, Bivalve Opening
• Version Model Number: Boston Body Jacket, Bivalve Opening
• Catalog Number: Boston Body Jacket, Bivalve Opening
• Company DUNS: 801816158
• Company Name: Boston Brace International, 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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	00860014460814 [Primary]

FDA Product Code

• IQE: Orthosis, Lumbar

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: 2025-08-13
• Device Publish Date: 2025-08-05

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
• 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