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Tronex International, Inc.

FDA UDI

Class I (US FDA UDI)

by Tronex International, Inc.

Identity

Trade Name
Tronex International, Inc. FDA UDI
Generic Name
Visitor hygiene coverall FDA UDI
Device Name
Coverall, Multilayer, Elastic Cuffs, Open Ankles, Fluid Resistant, Latex-Free, White, 4X-Large FDA UDI
Model / Reference
SMS815450W FDA UDI
Description
Coverall, Multilayer, Elastic Cuffs, Open Ankles, Fluid Resistant, Latex-Free, White, 4X-Large FDA UDI

Identifiers

Primary DI / UDI-DI
10097604815472 FDA UDI
FDA Product Code
LYU FDA UDI
GMDN Term
Visitor hygiene coverall FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4040 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Visitor hygiene coverall

Tronex International, Inc. by Tronex International, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Visitor hygiene coverall.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Tronex International, Inc.

Sources (1)

  • FDA UDI 2740a3b7-00f8-4047-ae34-a196a9f00660 33 fields · synced May 31, 2026