Curaplex

FDA UDI

Class I (US FDA UDI)

by Tri-Anim Health Services, Inc.

Identity

Trade Name: Curaplex FDA UDI
Generic Name: Laryngoscope handle, single-use FDA UDI
Device Name: Curaplex Penlite LED Handle FDA UDI
Model / Reference: 301-H1126-2 FDA UDI
Description: Curaplex Penlite LED Handle FDA UDI

Identifiers

Catalog Number: 301-H1126-2 FDA UDI
Primary DI / UDI-DI: 00812574026092 FDA UDI
FDA Product Code: CCW FDA UDI
GMDN Term: Laryngoscope handle, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.5540 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

Yes

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Laryngoscope handle, single-use

Curaplex by Tri-Anim Health Services, 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: Tri-Anim Health Services, Inc.

Sources (1)

FDA UDI 83cb440b-e29b-46b0-ad68-33670ffba01c 34 fields · synced Jun 8, 2026