Home GUDID 00097604815437 Tronex International, Inc.
Primary DI 00097604815437
Brand Tronex International, Inc.
Company TRONEX INTERNATIONAL, INC.
Model SMS815430W
Device description Coverall, Multilayer, Elastic Cuffs, Open Ankles, Fluid Resistant, Latex-Free, White, Large
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 LYU Accessory, Surgical Apparel
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LYU Accessory, Surgical Apparel General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10097604815434 Primary GS1 0 00097604815437 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 10097604815434 10097604815434 00097604815437 00097604815437 097604815437 0097604815437
GMDN Terms# Term, Definition table Term Definition Visitor hygiene coverall A garment intended to be worn by a visitor, or staff, in a healthcare facility as temporary clean clothing when with patients in non-sterile environments that may require a higher level of hygiene than a normal patient ward [e.g., intensive care unit (ICU), postoperative recovery ward]. Also known as a jump suit, it is a one-piece suit (overall) with sleeves, trouser legs, and fasteners intended to be worn over existing clothing to provide a barrier to help prevent cross-contamination of infectious agents between visitor and patients. This is a single-use garment.
Regulatory Flags# DUNS number 615425519 Device count 25 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 00097604555517 Tronex International, Inc. 5555W 2025-07-28 00097604577021 Tronex International, Inc. 577025W 2025-07-24 00097604577045 Tronex International, Inc. 577035W 2025-07-24 00097604130585 Tronex International, Inc. TCB0305C 2025-05-01 00097604140584 Tronex International, Inc. TCB0405C 2025-05-01 00097604160582 Tronex International, Inc. TCB0605C 2025-05-01 00097604220583 Tronex International, Inc. TLB2205L 2025-05-01 00097604330589 Tronex International, Inc. TLB3305L 2025-05-01 00097604440585 Tronex International, Inc. TLB4405L 2025-05-01 00097604660587 Tronex International, Inc. TLB6605L 2025-05-01 00097604015561 Tronex International, Inc. TCB0155R 2025-01-28 00097604010580 Tronex International, Inc. TCB0105C 2024-12-30 00097604020589 Tronex International, Inc. TCB0205C 2024-12-30 00097604110587 Tronex International, Inc. TCB1105A 2024-12-30 00097604120586 Tronex International, Inc. TCB1205A 2024-12-30 00097604212199 Tronex International, Inc. SD2121 2024-12-30 00097604215190 Tronex International, Inc. SD2151 2024-12-30 00097604313193 Tronex International, Inc. SD3131 2024-12-30 00097604422291 Tronex International, Inc. TCB4222N 2024-12-30 00097604423397 Tronex International, Inc. TCB4233N 2024-12-30
Other Devices Sharing Product Codes#