Facemask

FDA UDI

Class II (US FDA UDI)

by Ortho Organizers, Inc.

Identity

Trade Name: FACEMASK FDA UDI
Generic Name: Orthodontic extraoral headgear FDA UDI
Device Name: ADJUSTABLE FACEMASK-RED FDA UDI
Model / Reference: 426-056 FDA UDI
Description: ADJUSTABLE FACEMASK-RED FDA UDI

Identifiers

Primary DI / UDI-DI: 00190707057183 FDA UDI
FDA Product Code: DZB FDA UDI
GMDN Term: Orthodontic extraoral headgear FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.5500 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Orthodontic extraoral headgear

Facemask by Ortho Organizers, Inc. — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Ortho Organizers, Inc.

Sources (1)

FDA UDI f7e1544c-2362-461b-87b6-c27ac5401ad9 33 fields · synced Jun 9, 2026