FDA.reportPublic FDA data

Tronex International, Inc.

Primary DI
10097604599921
Brand
Tronex International, Inc.
Company
TRONEX INTERNATIONAL, INC.
Model
5999C
Device description
Face shield, polyester anti-fog film, soft foam headband, elastic strap, latex-free, full length, unisize
Published
2025-09-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FXOSuit, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FXOSuit, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10097604599921PrimaryGS10
00097604599924Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1009760459992110097604599921
00097604599924000976045999240976045999240097604599924

GMDN Terms#

Term, Definition table
TermDefinition
Face splash shield, single-useA clear, transparent guard intended to provide full face cover, to protect (shield) the healthcare worker from blood and other body fluid splashes while performing a clinical or laboratory procedure. It is commonly known as a splash shield. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
615425519
Device count
120
Premarket exempt
true

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
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
10097604330586Tronex International, Inc.TLB3305L2025-05-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889813060179Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCFXO2023-08-30
00889813060186Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCFXO2023-08-30
00889813060193Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCFXO2023-08-30
10889813060176Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCFXO2023-08-30
10889813060183Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCFXO2023-08-30
10889813060190Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCFXO2023-08-30
06921340881118customizedQingdao Bestex Rubber & Plastic Products Co., Ltd.FXO2023-06-16
06921340882115customizedQingdao Bestex Rubber & Plastic Products Co., Ltd.FXO2023-06-16
06921340883112customizedQingdao Bestex Rubber & Plastic Products Co., Ltd.FXO2023-06-16
06921340884119customizedQingdao Bestex Rubber & Plastic Products Co., Ltd.FXO2023-06-16
06921340885116customizedQingdao Bestex Rubber & Plastic Products Co., Ltd.FXO2023-06-16
16921340881115customizedQingdao Bestex Rubber & Plastic Products Co., Ltd.FXO2023-06-16
16921340882112customizedQingdao Bestex Rubber & Plastic Products Co., Ltd.FXO2023-06-16
16921340883119customizedQingdao Bestex Rubber & Plastic Products Co., Ltd.FXO2023-06-16
16921340884116customizedQingdao Bestex Rubber & Plastic Products Co., Ltd.FXO2023-06-16
16921340885113customizedQingdao Bestex Rubber & Plastic Products Co., Ltd.FXO2023-06-16
06973635612013MaoshengXianTao Maosheng Plastic Products Co., LtdFXO2023-03-31
10850044799593SURGYCOSurgyco LLCFXO2023-02-16
10850044799609SURGYCOSurgyco LLCFXO2023-02-16
10850044799616SURGYCOSurgyco LLCFXO2023-02-16
10850044799623SURGYCOSurgyco LLCFXO2023-02-16
10850044799630SURGYCOSurgyco LLCFXO2023-02-16
10850044799647SURGYCOSurgyco LLCFXO2023-02-16
10850044799654SURGYCOSurgyco LLCFXO2023-02-16
10850044799661SURGYCOSurgyco LLCFXO2023-02-16
10850044799678SURGYCOSurgyco LLCFXO2023-02-16
10850044799685SURGYCOSurgyco LLCFXO2023-02-16
00850044799596SURGYCOSurgyco LLCFXO2023-02-16
00850044799602SURGYCOSurgyco LLCFXO2023-02-16
00850044799619SURGYCOSurgyco LLCFXO2023-02-16