Primary Device ID | 00860010708118 |
NIH Device Record Key | b7630ba2-9435-445c-a9df-36da7cc25762 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Boston Brace |
Version Model Number | Scoliosis: Boston 3D-Finished Boston |
Catalog Number | Scoliosis: Boston 3D-Finished Boston |
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 | 00860010708118 [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 |