← Back to catalogue

Tronex International, Inc.

FDA UDI

Class II (US FDA UDI)

by Tronex International, Inc.

Identity

Trade Name
Tronex International, Inc. FDA UDI
Generic Name
Surgical/medical face mask, non-antimicrobial, single-use FDA UDI
Device Name
Mask, Procedure, Spunbond, Earloops, Fluid Resistant, Dotted Print, Child Unisize FDA UDI
Model / Reference
5611D FDA UDI
Description
Mask, Procedure, Spunbond, Earloops, Fluid Resistant, Dotted Print, Child Unisize FDA UDI

Identifiers

Primary DI / UDI-DI
10097604561126 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

No

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

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

Tronex International, Inc. by Tronex International, Inc. — 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
Tronex International, Inc.

Sources (1)

  • FDA UDI cf272f97-fe44-4cd8-9ae4-2e3e9ed74df2 33 fields · synced Jun 8, 2026