Home GUDID 00097604010023 Tronex International, Inc.
Primary DI 00097604010023
Brand Tronex International, Inc.
Company TRONEX INTERNATIONAL, INC.
Model SMS10025Y
Device description Gown, Isolation, Multilayer, Elastic Cuffs, Fluid Resistant, Latex-Free, Yellow, Unisize
Published 2022-10-28
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Safe
Rx false
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name OEA Non-Surgical Isolation Gown
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OEA Non-Surgical Gown General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10097604010020 Primary GS1 0 00097604010023 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10097604010020 10097604010020 00097604010023 00097604010023 097604010023 0097604010023
GMDN Terms# Term, Definition table Term Definition Isolation gown, single-use A 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 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch false Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 10097604912805 Tronex International, Inc. 9128-05 2022-10-28 10097604912812 Tronex International, Inc. 9128-10 2022-10-28 10097604912829 Tronex International, Inc. 9128-20 2022-10-28 10097604912836 Tronex International, Inc. 9128-30 2022-10-28 10097604912843 Tronex International, Inc. 9128-35 2022-10-28 10097604912850 Tronex International, Inc. 9128-40 2022-10-28 10097604599921 Tronex International, Inc. 5999C 2025-09-10 10097604451250 Tronex International, Inc. SMS45125Y 2022-10-28 10097604453353 Tronex International, Inc. SMS45335Y 2022-10-28 10097604555514 Tronex International, Inc. 5555W 2025-07-28 00097604555517 Tronex International, Inc. 5555W 2025-07-28 10097604577028 Tronex International, Inc. 577025W 2025-07-24 10097604577042 Tronex International, Inc. 577035W 2025-07-24 00097604577021 Tronex International, Inc. 577025W 2025-07-24 00097604577045 Tronex International, Inc. 577035W 2025-07-24 10097604110577 Tronex International, Inc. TLB1105L 2025-05-05 10097604130582 Tronex International, Inc. TCB0305C 2025-05-01 10097604140581 Tronex International, Inc. TCB0405C 2025-05-01 10097604160589 Tronex International, Inc. TCB0605C 2025-05-01 10097604220580 Tronex International, Inc. TLB2205L 2025-05-01
Other Devices Sharing Product Codes#