FDA.reportPublic FDA data

Tronex International, Inc.

Primary DI
10097604553022
Brand
Tronex International, Inc.
Company
TRONEX INTERNATIONAL, INC.
Model
5530B
Device description
Mask, Surgical, Spunbond, ASTM Level 3, Anti-Fog Foam Strip, Eyeshield, Tie-on, Fluid Resistant, Blue, Unisize
Published
2024-01-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FXXMask, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FXXMask, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10097604553022PrimaryGS10
00097604553025Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1009760455302210097604553022
00097604553025000976045530250976045530250097604553025

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/medical face mask, non-antimicrobial, single-useA flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials). It does not include an antimicrobial/antiviral agent(s) and it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or transparent face/eye visor. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
973-335-2888tronexproductmanagement@tronexcompany.com

Regulatory Flags#

DUNS number
615425519
Device count
200

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10097604912805Tronex International, Inc.9128-052022-10-28
10097604912812Tronex International, Inc.9128-102022-10-28
10097604912829Tronex International, Inc.9128-202022-10-28
10097604912836Tronex International, Inc.9128-302022-10-28
10097604912843Tronex International, Inc.9128-352022-10-28
10097604912850Tronex International, Inc.9128-402022-10-28
10097604599921Tronex International, Inc.5999C2025-09-10
10097604451250Tronex International, Inc.SMS45125Y2022-10-28
10097604453353Tronex International, Inc.SMS45335Y2022-10-28
10097604555514Tronex International, Inc.5555W2025-07-28
00097604555517Tronex International, Inc.5555W2025-07-28
10097604577028Tronex International, Inc.577025W2025-07-24
10097604577042Tronex International, Inc.577035W2025-07-24
00097604577021Tronex International, Inc.577025W2025-07-24
00097604577045Tronex International, Inc.577035W2025-07-24
10097604110577Tronex International, Inc.TLB1105L2025-05-05
10097604130582Tronex International, Inc.TCB0305C2025-05-01
10097604140581Tronex International, Inc.TCB0405C2025-05-01
10097604160589Tronex International, Inc.TCB0605C2025-05-01
10097604220580Tronex International, Inc.TLB2205L2025-05-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809755250171KP Protective Face Mask KP trading Co., Ltd.FXX2026-02-19
10097604555514Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2025-07-28
10371347011606Advance Dental ProductsThe Atlanta Dental Supply CompanyFXX2024-03-01
10371347011613Advance Dental ProductsThe Atlanta Dental Supply CompanyFXX2024-03-01
10371347011620Advance Dental ProductsThe Atlanta Dental Supply CompanyFXX2024-03-01
10097604543320Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2024-01-19
10097604563229Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2024-01-19
10097604573624Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2024-01-19
10195327560522Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FXX2023-12-21
10097604537022Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2023-12-11
10097604538128Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2023-12-11
10304040169022EssentialsHENRY SCHEIN, INC.FXX2023-07-05
10304040169039EssentialsHENRY SCHEIN, INC.FXX2023-07-05
10304040169046CriterionHENRY SCHEIN, INC.FXX2023-07-05
10304040165253CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040165260CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168483CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168490CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168582CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168612CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168629CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168643CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168650CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168926CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168933CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168940CriterionHENRY SCHEIN, INC.FXX2023-06-26
10087701434423Good NeighborShepard Medical Products, Inc.FXX2023-01-06
10096295122296LeaderShepard Medical Products, Inc.FXX2023-01-06
10096295137382LeaderShepard Medical Products, Inc.FXX2023-01-06
10097604504024Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2022-10-28