Giggle Monster Face Masks

FDA UDI

Class II (US FDA UDI)

by Practicon, Inc.

Identity

Trade Name: Giggle Monster Face Masks FDA UDI
Generic Name: Surgical/medical face mask, single-use FDA UDI
Device Name: Level 2 Dental Earloop Facemask FDA UDI
Model / Reference: 7147610 FDA UDI
Description: Level 2 Dental Earloop Facemask FDA UDI

Identifiers

Catalog Number: 7147610 FDA UDI
Primary DI / UDI-DI: 00723896016121 FDA UDI
510(k) Number: K182514 FDA UDI
FDA Product Code: FXX FDA UDI
GMDN Term: Surgical/medical face mask, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4040 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

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

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Surgical/medical face mask, single-use

Giggle Monster Face Masks by Practicon, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical/medical face mask, single-use.

ProGear — Prestige Ameritech · Class II
Precept® — Precept Medical Products, Inc. · Class II
hcs — DYAD MEDICAL SOURCING, LLC · Class I
Precept® — Precept Medical Products, Inc. · Class II
AOSHANG — Tianjin Aoshang Outdoor Equipment Co., Ltd. · Class II
Precept® — Precept Medical Products, Inc. · Class II
Precept® — Precept Medical Products, Inc. · Class II
Surgical Face Mask — Foshan Nanhai Plus Medical Co., Ltd · Class II

Cleared under the same submission

K182514 also covers:

Jointown — US HEALTH EXPRESS CORP

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: Practicon, Inc.

Sources (1)

FDA UDI dc771a82-a821-42ee-915f-e058e38f147c 35 fields · synced May 31, 2026