| Primary Device ID | 00860010708125 |
| NIH Device Record Key | ff64041b-7f9a-43c5-a487-4c6a1a294388 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Boston Brace |
| Version Model Number | Scoliosis: Boston Scoli-NightShift |
| Catalog Number | Scoliosis: Boston Scoli-NightShift |
| 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 | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860010708125 [Primary] |
| IQE | Orthosis, Lumbar |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-08 |
| Device Publish Date | 2024-04-30 |
| 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 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() BOSTON BRACE 87427900 5389975 Live/Registered |
BOSTON BRACE 2017-04-27 |
![]() BOSTON BRACE 74237339 not registered Dead/Abandoned |
O & P SYSTEMS, INC. 1992-01-13 |