Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3044142720

FEI Number

3044142720

Entity Name

DIME-PACK S. De R.L. De C.V.

City/State/Country

Tijuana Baja California, MX

Establishment Address

Camino Viejo A Tecate 9120, Col. Ninos Heroes Este, Tijuana Baja California 22120, MX

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Onyx Industries, Inc. (Owner Number: 2025291)

Owner / Operator Contact Address

521 W. Rosecrans Ave., --, Gardena, CA 90248, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MEDISEPT STUDEX MEDISEPT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2013-11-26
KAY	Punch, Nasal	Ear, Nose, Throat	Class 1	874.4420	2013-11-14
JYS	Perforator, Ear-Lobe	Ear, Nose, Throat	Class 1	874.4420	1992-10-05
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	2013-11-26

Official Correspondent

Leanne Kim

US Agent Details

Leanne Kim Email: leannekim@onyxindustries.com Phone: (310) 8519300

Related Public Records

Same Entity

Onyx Industries, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
2025291	ONYX INDUSTRIES, INC.	GARDENA, CA, US

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2084346	MARINA MEDICAL INSTRUMENTS, INC.	Davie, FL, US
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3004111573	Sterigenics US LLC	Grand Prairie, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3044142720. Last updated year: 2026. Please use registration number 3044142720 when referencing this establishment in official correspondence.