Tronex International, Inc.

FDA UDI

Class I (US FDA UDI)

by Tronex International, Inc.

Identity

Trade Name: Tronex International, Inc. FDA UDI
Generic Name: Shoe cover FDA UDI
Device Name: Cover, Boot, Coated Spunbond, Hook & Loop Closure, Foam Strip Non-Skid Tread, Fluid Impervious, Latex-Free, Blue, Unisize FDA UDI
Model / Reference: 48825B FDA UDI
Description: Cover, Boot, Coated Spunbond, Hook & Loop Closure, Foam Strip Non-Skid Tread, Fluid Impervious, Latex-Free, Blue, Unisize FDA UDI

Identifiers

Primary DI / UDI-DI: 10097604488256 FDA UDI
FDA Product Code: FXP FDA UDI
GMDN Term: Shoe cover 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

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: Shoe cover

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 22ec3093-8f35-44ef-af6d-a22495c1b5c9 33 fields · synced May 30, 2026