Boston Brace Boston Brace Baby

GUDID 00860010708187

Boston Brace Baby

Boston Brace International, Inc.

Multiple spinal region orthosis Multiple spinal region orthosis Multiple spinal region orthosis Multiple spinal region orthosis Multiple spinal region orthosis Multiple spinal region orthosis Multiple spinal region orthosis Multiple spinal region orthosis Multiple spinal region orthosis Multiple spinal region orthosis Multiple spinal region orthosis Multiple spinal region orthosis Multiple spinal region orthosis Multiple spinal region orthosis Multiple spinal region orthosis Multiple spinal region orthosis Multiple spinal region orthosis

• Primary Device ID: 00860010708187
• NIH Device Record Key: 81cd07a1-3953-4235-8429-b971ff070f7f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Boston Brace
• Version Model Number: Boston Brace Baby
• Catalog Number: Boston Brace Baby
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 800.262.2235
• Email: customerservices@bostonoandp.com
• Phone: 800.262.2235
• Email: customerservices@bostonoandp.com
• Phone: 800.262.2235
• Email: customerservices@bostonoandp.com
• Phone: 800.262.2235
• Email: customerservices@bostonoandp.com
• Phone: 800.262.2235
• Email: customerservices@bostonoandp.com
• Phone: 800.262.2235
• Email: customerservices@bostonoandp.com
• Phone: 800.262.2235
• Email: customerservices@bostonoandp.com
• Phone: 800.262.2235
• Email: customerservices@bostonoandp.com
• Phone: 800.262.2235
• Email: customerservices@bostonoandp.com
• Phone: 800.262.2235
• Email: customerservices@bostonoandp.com
• Phone: 800.262.2235
• Email: customerservices@bostonoandp.com
• Phone: 800.262.2235
• Email: customerservices@bostonoandp.com
• Phone: 800.262.2235
• Email: customerservices@bostonoandp.com
• Phone: 800.262.2235
• Email: customerservices@bostonoandp.com
• Phone: 800.262.2235
• Email: customerservices@bostonoandp.com
• Phone: 800.262.2235
• Email: customerservices@bostonoandp.com
• Phone: 800.262.2235
• Email: customerservices@bostonoandp.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860010708187 [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: 2024-06-18
• Device Publish Date: 2024-06-10

On-Brand Devices [Boston Brace]

• 00860010708156: Boston Scoli-Finish-Kyphosis with Cowhorns
• 00860010708149: Boston Scoli-Finish
• 00860010708132: Soft Body Jacket-single open- finished
• 00860010708125: Boston Scoli-Finish-Nighttime/ Night Shift
• 00860010708118: Boston 3D-Finished
• 00860010708187: Boston Brace Baby
• 00860010708170: Boston Brace RC
• 00860010708163: Boston Brace Original