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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
Surgical hood FDA UDI
Device Name
Cap, Bouffant, Spunbond, Fluid Resistant, Latex-Free, White, 24" FDA UDI
Model / Reference
4140W FDA UDI
Description
Cap, Bouffant, Spunbond, Fluid Resistant, Latex-Free, White, 24" FDA UDI

Identifiers

Primary DI / UDI-DI
10097604414019 FDA UDI
FDA Product Code
FYF FDA UDI
GMDN Term
Surgical hood 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: Surgical hood

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

Similar devices

Also classified as Surgical hood.

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 e03bf60b-9888-4773-905b-7ce7ed67409e 34 fields · synced Jun 8, 2026