Boston Brace

FDA UDI

Class I (US FDA UDI)

by Boston Brace International, Inc.

Identity

Trade Name: Boston Brace FDA UDI
Generic Name: Multiple spinal region orthosis FDA UDI
Device Name: Boston Night Shift FDA UDI
Model / Reference: Scoliosis: Boston Scoli-NightShift FDA UDI
Description: Boston Night Shift FDA UDI

Identifiers

Catalog Number: Boston Night Shift FDA UDI
Primary DI / UDI-DI: 00860010708125 FDA UDI
FDA Product Code: IQE FDA UDI
IPT FDA UDI
GMDN Term: Multiple spinal region orthosis FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 890.3490 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Multiple spinal region orthosis

Boston Brace by Boston Brace International, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Boston Brace International, Inc.

Sources (1)

FDA UDI ff64041b-7f9a-43c5-a487-4c6a1a294388 35 fields · synced May 30, 2026