FDA.reportPublic FDA data

Tronex International, Inc.

Primary DI
10097604453353
Brand
Tronex International, Inc.
Company
TRONEX INTERNATIONAL, INC.
Model
SMS45335Y
Device description
Gown, Isolation, Multilayer, Over-the-Head Thumb-Hook, Fluid Resistant, Latex-Free, Yellow, Extra-Large
Published
2022-10-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Single use
true

Product Codes#

Code, Name table
CodeName
FMEGown, Examination
OEANon-Surgical Isolation Gown

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMEGown, ExaminationGeneral Hospital1
OEANon-Surgical GownGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10097604453353PrimaryGS10
00097604453356Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1009760445335310097604453353
00097604453356000976044533560976044533560097604453356

GMDN Terms#

Term, Definition table
TermDefinition
Isolation gown, single-useA garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients. The isolation gown helps to protect the patient (e.g., burn patients) from the transfer of infectious agents carried by the healthcare provider or visitor; or it may help to protect the healthcare provider or visitor from a contagious agent which has infected the patient. This is a single-use garment.

Regulatory Flags#

DUNS number
615425519
Device count
100
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
10097604599921Tronex International, Inc.5999C2025-09-10
10097604451250Tronex International, Inc.SMS45125Y2022-10-28
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
10097604577028Tronex International, Inc.TRONEX INTERNATIONAL, INC.OEA2025-07-24
10097604577042Tronex International, Inc.TRONEX INTERNATIONAL, INC.OEA2025-07-24
20885380151511CARDINAL HEALTHCARDINAL HEALTH 200, LLCOEA2025-03-22
10097604573327Tronex International, Inc.TRONEX INTERNATIONAL, INC.FME2024-12-30
10197106472408CARDINAL HEALTHCardinal Health 200, LLCOEA2024-10-07
10097604466407Tronex International, Inc.TRONEX INTERNATIONAL, INC.OEA2024-09-16
10193489099560MEDLINEMEDLINE INDUSTRIES, INC.OEA2024-07-04
10197106650493CARDINAL HEALTHCardinal Health 200, LLCOEA2024-06-10
10197106652565CARDINAL HEALTHCardinal Health 200, LLCOEA2024-06-07
10197106648605CARDINAL HEALTHCardinal Health 200, LLCOEA2024-05-20
10197106621349CARDINAL HEALTHCardinal Health 200, LLCOEA2024-05-16
10197106636480CARDINAL HEALTHCardinal Health 200, LLCOEA2024-05-16
10197106645918CARDINAL HEALTHCardinal Health 200, LLCOEA2024-05-07
10197106646625CARDINAL HEALTHCardinal Health 200, LLCOEA2024-05-02
10197106653296CARDINAL HEALTHCardinal Health 200, LLCOEA2024-04-29
10197106627259CARDINAL HEALTHCardinal Health 200, LLCOEA2024-04-17
10197106589380CARDINAL HEALTHCardinal Health 200, LLCOEA2024-04-08
10197106592151CARDINAL HEALTHCardinal Health 200, LLCOEA2024-04-08
10197106613801CARDINAL HEALTHCardinal Health 200, LLCOEA2024-03-26
10197106489062CARDINAL HEALTHCardinal Health 200, LLCOEA2024-03-20
10197106558959CARDINAL HEALTHCardinal Health 200, LLCOEA2024-03-11
10197106597842CARDINAL HEALTHCardinal Health 200, LLCOEA2024-03-06
10197106561904CARDINAL HEALTHCardinal Health 200, LLCOEA2024-02-08
10197106525074CARDINAL HEALTHCardinal Health 200, LLCOEA2024-02-07
10197106549636CARDINAL HEALTHCardinal Health 200, LLCOEA2024-01-30
10197106511336CARDINAL HEALTHCardinal Health 200, LLCOEA2024-01-23
10197106530337CARDINAL HEALTHCardinal Health 200, LLCOEA2024-01-08
10197106530443CARDINAL HEALTHCardinal Health 200, LLCOEA2024-01-08
10197106515006CARDINAL HEALTHCardinal Health 200, LLCOEA2024-01-03
10197106464311CARDINAL HEALTHCardinal Health 200, LLCOEA2023-12-19