Uniweb Surgical Mask

FDA UDI

Class II (US FDA UDI)

by Universal Incorporation

Identity

Trade Name: UNIWEB SURGICAL MASK FDA UDI
Generic Name: Surgical/medical face mask, single-use FDA UDI
Device Name: The Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material. This device is intended for adult use Only. The UNIWEB Surgical Masks are single use, disposable device, provided non-sterile. FDA UDI
Model / Reference: ASTM Level 2 FDA UDI
Description: The Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material. This device is intended for adult use Only. The UNIWEB Surgical Masks are single use, disposable device, provided non-sterile. FDA UDI

Identifiers

Primary DI / UDI-DI: 04715243610140 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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Surgical/medical face mask, single-use

Uniweb Surgical Mask by Universal Incorporation — 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

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: Universal Incorporation

Sources (1)

FDA UDI 48cfb111-0c1b-445a-a136-716ebcf0523e 34 fields · synced May 30, 2026