Tronex International, Inc.

FDA UDI

Class I (US FDA UDI)

by Tronex International, Inc.

Identity

Trade Name: Tronex International, Inc. FDA UDI
Generic Name: Isolation gown, single-use FDA UDI
Device Name: Gown, Isolation, Cast Polyethylene, Over-the-Head Thumb-Hook, Fluid Impervious, Latex-Free, Blue, Extra-Large FDA UDI
Model / Reference: 6033C35 FDA UDI
Description: Gown, Isolation, Cast Polyethylene, Over-the-Head Thumb-Hook, Fluid Impervious, Latex-Free, Blue, Extra-Large FDA UDI

Identifiers

Primary DI / UDI-DI: 10097604603345 FDA UDI
FDA Product Code: FYE FDA UDI
OEA FDA UDI
FME FDA UDI
GMDN Term: Isolation gown, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4040 FDA UDI
880.6265 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Isolation gown, single-use

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

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Tronex International, Inc.

Sources (1)

FDA UDI 93943a01-8a26-41c8-84ab-de1282d03cea 33 fields · synced May 31, 2026