Boston Band
GUDID 00860010708101
Boston Band custom cranial remolding orthosis
Boston Orthotics & Prosthetics
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
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 |
Trademark Results [Boston Band]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BOSTON BAND 87427953 5389976 Live/Registered |
BOSTON BRACE 2017-04-27 |
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