Boston Band

GUDID 00860010708101

Boston Band custom cranial remolding orthosis

Boston Orthotics & Prosthetics

Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis

• Primary Device ID: 00860010708101
• NIH Device Record Key: 97f906f8-e5cd-4558-892f-8f3bcb71c9c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Boston Band
• Version Model Number: BB1
• Company DUNS: 801816158
• Company Name: Boston Orthotics & Prosthetics
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: 8002622235
• Email: customerservice@bostonoandp.com
• Phone: 8002622235
• Email: customerservice@bostonoandp.com
• Phone: 8002622235
• Email: customerservice@bostonoandp.com
• Phone: 8002622235
• Email: customerservice@bostonoandp.com
• Phone: 8002622235
• Email: customerservice@bostonoandp.com
• Phone: 8002622235
• Email: customerservice@bostonoandp.com
• Phone: 8002622235
• Email: customerservice@bostonoandp.com
• Phone: 8002622235
• Email: customerservice@bostonoandp.com
• Phone: 8002622235
• Email: customerservice@bostonoandp.com
• Phone: 8002622235
• Email: customerservice@bostonoandp.com
• Phone: 8002622235
• Email: customerservice@bostonoandp.com
• Phone: 8002622235
• Email: customerservice@bostonoandp.com
• Phone: 8002622235
• Email: customerservice@bostonoandp.com
• Phone: 8002622235
• Email: customerservice@bostonoandp.com
• Phone: 8002622235
• Email: customerservice@bostonoandp.com
• Phone: 8002622235
• Email: customerservice@bostonoandp.com
• Phone: 8002622235
• Email: customerservice@bostonoandp.com
• Phone: 8002622235
• Email: customerservice@bostonoandp.com
• Phone: 8002622235
• Email: customerservice@bostonoandp.com
• Phone: 8002622235
• Email: customerservice@bostonoandp.com
• Phone: 8002622235
• Email: customerservice@bostonoandp.com
• Phone: 8002622235
• Email: customerservice@bostonoandp.com
• Phone: 8002622235
• Email: customerservice@bostonoandp.com
• Phone: 8002622235
• Email: customerservice@bostonoandp.com
• Phone: 8002622235
• Email: customerservice@bostonoandp.com
• Phone: 8002622235
• Email: customerservice@bostonoandp.com
• Phone: 8002622235
• Email: customerservice@bostonoandp.com
• Phone: 8002622235
• Email: customerservice@bostonoandp.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860010708101 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111609

FDA Product Code

• MVA: Orthosis, Cranial

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: 2023-09-21
• Device Publish Date: 2023-09-13