← Back to catalogue

Dukal

FDA UDI

Class II (US FDA UDI)

by Dukal LLC

Identity

Trade Name
Dukal FDA UDI
Generic Name
Surgical/medical face mask, non-antimicrobial, single-use FDA UDI
Device Name
Surgical Mask, Level 2, Blue Earloop, NS FDA UDI
Model / Reference
1580 FDA UDI
Description
Surgical Mask, Level 2, Blue Earloop, NS FDA UDI

Identifiers

Catalog Number
1580 FDA UDI
Primary DI / UDI-DI
10665973028894 FDA UDI
510(k) Number
K201421 FDA UDI
FDA Product Code
FXX FDA UDI
GMDN Term
Surgical/medical face mask, non-antimicrobial, 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Surgical/medical face mask, non-antimicrobial, single-use

Dukal by Dukal LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Dukal LLC

Sources (1)

  • FDA UDI 2b4bd7da-0aaf-4c3d-85b3-4f2cb30e3379 36 fields · synced May 30, 2026