Tronex International, Inc.

FDA UDI

Class I (US FDA UDI)

by Tronex International, Inc.

Identity

Trade Name: Tronex International, Inc. FDA UDI
Generic Name: Woven gauze roll/sheet FDA UDI
Device Name: Bandage, Elastic, Dual Self Closure, Sterile, Latex-Free, Natural, 3"x5yds FDA UDI
Model / Reference: EBS6421S FDA UDI
Description: Bandage, Elastic, Dual Self Closure, Sterile, Latex-Free, Natural, 3"x5yds FDA UDI

Identifiers

Primary DI / UDI-DI: 10097604642191 FDA UDI
FDA Product Code: FQM FDA UDI
GMDN Term: Woven gauze roll/sheet FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 880.5075 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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: Woven gauze roll/sheet

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 35a19ee6-71db-4d64-bc23-0264271c67b8 34 fields · synced May 30, 2026