Boston Brace Scoliosis: Boston 3D-Finished Boston

GUDID 00860010708118

Boston 3D-Finished

Boston Brace International, Inc.

Multiple spinal region orthosis
Primary Device ID00860010708118
NIH Device Record Keyb7630ba2-9435-445c-a9df-36da7cc25762
Commercial Distribution StatusIn Commercial Distribution
Brand NameBoston Brace
Version Model NumberScoliosis: Boston 3D-Finished Boston
Catalog NumberScoliosis: Boston 3D-Finished Boston
Company DUNS801816158
Company NameBoston Brace International, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone800.262.2235
Emailcustomerservices@bostonoandp.com
Phone800.262.2235
Emailcustomerservices@bostonoandp.com
Phone800.262.2235
Emailcustomerservices@bostonoandp.com
Phone800.262.2235
Emailcustomerservices@bostonoandp.com
Phone800.262.2235
Emailcustomerservices@bostonoandp.com
Phone800.262.2235
Emailcustomerservices@bostonoandp.com
Phone800.262.2235
Emailcustomerservices@bostonoandp.com
Phone800.262.2235
Emailcustomerservices@bostonoandp.com
Phone800.262.2235
Emailcustomerservices@bostonoandp.com
Phone800.262.2235
Emailcustomerservices@bostonoandp.com
Phone800.262.2235
Emailcustomerservices@bostonoandp.com
Phone800.262.2235
Emailcustomerservices@bostonoandp.com
Phone800.262.2235
Emailcustomerservices@bostonoandp.com
Phone800.262.2235
Emailcustomerservices@bostonoandp.com
Phone800.262.2235
Emailcustomerservices@bostonoandp.com
Phone800.262.2235
Emailcustomerservices@bostonoandp.com
Phone800.262.2235
Emailcustomerservices@bostonoandp.com
Phone800.262.2235
Emailcustomerservices@bostonoandp.com
Phone800.262.2235
Emailcustomerservices@bostonoandp.com
Phone800.262.2235
Emailcustomerservices@bostonoandp.com
Phone800.262.2235
Emailcustomerservices@bostonoandp.com
Phone800.262.2235
Emailcustomerservices@bostonoandp.com
Phone800.262.2235
Emailcustomerservices@bostonoandp.com
Phone800.262.2235
Emailcustomerservices@bostonoandp.com
Phone800.262.2235
Emailcustomerservices@bostonoandp.com
Phone800.262.2235
Emailcustomerservices@bostonoandp.com
Phone800.262.2235
Emailcustomerservices@bostonoandp.com
Phone800.262.2235
Emailcustomerservices@bostonoandp.com
Phone800.262.2235
Emailcustomerservices@bostonoandp.com
Phone800.262.2235
Emailcustomerservices@bostonoandp.com
Phone800.262.2235
Emailcustomerservices@bostonoandp.com
Phone800.262.2235
Emailcustomerservices@bostonoandp.com
Phone800.262.2235
Emailcustomerservices@bostonoandp.com
Phone800.262.2235
Emailcustomerservices@bostonoandp.com
Phone800.262.2235
Emailcustomerservices@bostonoandp.com
Phone800.262.2235
Emailcustomerservices@bostonoandp.com
Phone800.262.2235
Emailcustomerservices@bostonoandp.com
Phone800.262.2235
Emailcustomerservices@bostonoandp.com
Phone800.262.2235
Emailcustomerservices@bostonoandp.com
Phone800.262.2235
Emailcustomerservices@bostonoandp.com
Phone800.262.2235
Emailcustomerservices@bostonoandp.com
Phone800.262.2235
Emailcustomerservices@bostonoandp.com
Phone800.262.2235
Emailcustomerservices@bostonoandp.com
Phone800.262.2235
Emailcustomerservices@bostonoandp.com
Phone800.262.2235
Emailcustomerservices@bostonoandp.com
Phone800.262.2235
Emailcustomerservices@bostonoandp.com
Phone800.262.2235
Emailcustomerservices@bostonoandp.com
Phone800.262.2235
Emailcustomerservices@bostonoandp.com
Phone800.262.2235
Emailcustomerservices@bostonoandp.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100860010708118 [Primary]

FDA Product Code

IQEOrthosis, Lumbar

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-08
Device Publish Date2024-04-30

On-Brand Devices [Boston Brace]

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

Trademark Results [Boston Brace]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BOSTON BRACE
BOSTON BRACE
87427900 5389975 Live/Registered
BOSTON BRACE
2017-04-27
BOSTON BRACE
BOSTON BRACE
74237339 not registered Dead/Abandoned
O & P SYSTEMS, INC.
1992-01-13

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.