OPSB Sensor Mobile App

GUDID 00860013109813

Boston Brace International, Inc.

Wireless patient monitor/sensor reporting software, layperson-use
Primary Device ID00860013109813
NIH Device Record Key8975049d-579f-44c3-b13c-4c9736c66413
Commercial Distribution StatusIn Commercial Distribution
Brand NameOPSB Sensor Mobile App
Version Model NumberSENSOR-MA-V1
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100860013109813 [Primary]

FDA Product Code

OUGMedical Device Data System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-03
Device Publish Date2025-02-21

Devices Manufactured by Boston Brace International, Inc.

00860013109806 - OPSB Sensor2025-03-03 OPSB Sensor
00860013109813 - OPSB Sensor Mobile App2025-03-03
00860013109813 - OPSB Sensor Mobile App2025-03-03
00860013109820 - OPSB Sensor Web Portal2025-03-03
00860013109837 - OPSB Sensor Cloud Backend2025-03-03
00860010708163 - Boston Brace2024-06-18 Boston Brace Original
00860010708170 - Boston Brace2024-06-18 Boston Brace RC
00860010708187 - Boston Brace2024-06-18 Boston Brace Baby
00860010708118 - Boston Brace2024-05-08 Boston 3D-Finished

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