TruLock

FDA UDI

Class I (US FDA UDI)

by H R Pharmaceuticals, Inc.

Identity

Trade Name: TruLock FDA UDI
Generic Name: Personal device holder, reusable FDA UDI
Device Name: TruLock™ Foley Securement Device, For 2-Way Foley, Large Swivel Clamp on Mesh Cloth Base, and Skin Prep Pad FDA UDI
Model / Reference: TLFC1 FDA UDI
Description: TruLock™ Foley Securement Device, For 2-Way Foley, Large Swivel Clamp on Mesh Cloth Base, and Skin Prep Pad FDA UDI

Identifiers

Primary DI / UDI-DI: 00850058254333 FDA UDI
FDA Product Code: EYJ FDA UDI
GMDN Term: Personal device holder, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 876.5130 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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Personal device holder, reusable

TruLock by H R Pharmaceuticals, 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: H R Pharmaceuticals, Inc.

Sources (1)

FDA UDI 0bff74bb-98ac-4875-a10f-3ed3953f62a0 34 fields · synced May 29, 2026