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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
Pressure bandage, Hevea-latex, single-use FDA UDI
Device Name
Self Adherent Wrap, Non-Sterile, Latex , Tan, 6" x 5 yds FDA UDI
Model / Reference
TLB6605L FDA UDI
Description
Self Adherent Wrap, Non-Sterile, Latex , Tan, 6" x 5 yds FDA UDI

Identifiers

Primary DI / UDI-DI
10097604660584 FDA UDI
FDA Product Code
FQM FDA UDI
GMDN Term
Pressure bandage, Hevea-latex, single-use 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

Yes

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: Pressure bandage, Hevea-latex, single-use

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

Similar devices

Also classified as Pressure bandage, Hevea-latex, single-use.

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 987c1d7c-929c-4489-8bbf-d43660aad168 34 fields · synced May 29, 2026