Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9613558

FEI Number

3003215851

Entity Name

MAQUILADORA DE COAHUILA S DE RL DE CV

City/State/Country

CUIDAD ACUNA Coahuila, MX

Establishment Address

CARRETERA PRESA AMISTAD, KM 9.8, CUIDAD ACUNA Coahuila CP 26220, MX

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Border Opportunity Saver Systems, Inc. (Owner Number: 1640425)

Owner / Operator Contact Address

10 Finegan Road, Del Rio, TX 78840, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

KIMBERLY CLARK KIMBERLY CLARK KIMBERLY CLARK KIMBERLY CLARK Halyard Halyard KIMBERLY-CLARK SYSTAGENIX KIMBERLY CLARK KIMBERELY CLARK KIMBERLY CLARK

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IPM	Cover, Limb	Physical Medicine	Class 1	890.3025	2007-03-06
FME	Gown, Examination	General Hospital	Class 1	880.6265	2020-04-14
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2005-06-02
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2007-02-09
NZD	Stretcher, Patient Restraint	General Hospital	Class 1	880.6900	2008-03-07
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2016-05-06
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2017-12-04
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2024-04-09
JCY	Catheter, Infusion	General, Plastic Surgery	Class 1	878.4200	2007-02-09
MCY	Wound Dressing Kit	General Hospital	Class 2	880.5075	2008-03-07
ISR	Band Or Belt, Pelvic Support	Physical Medicine	Class 1	890.3025	2007-02-09
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2005-02-07
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2005-06-02
DSW	Bag, Polymeric Mesh, Pacemaker	Cardiovascular	Class 1	870.3650	2007-02-09

Official Correspondent

LEONEL MARTINEZ, JR.

US Agent Details

LEONEL MARTINEZ Leonel Martinez, Jr. Business: BORDER OPPORTUNITY SAVER SYSTEMS, INC. Email: lmtz@borderopp.com Phone: (830) 7751225

Related Public Records

Same Entity

Border Opportunity Saver Systems, 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
1640425	BORDER OPPORTUNITY SAVER SYSTEMS, INC.	Del Rio, TX, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K883982	Iberhospitex, S.A.	DRENOVAC	1989-02-23
K914369	Deroyal Industries, Inc.	QUALTEX MAGNETIC INSTRUMENT DRAPE	1991-12-02
K812809	Abco Dealers, Inc.	STERILE ADHERENT DRAPES	1981-11-06
K910084	Biocor Medical, Inc.	SURGICAL DRAPE	1991-03-19
K010462	Avita Corporation	AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)	2001-04-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-04	Vital Concepts, Inc.	1	Huntington Instruments brand Irrigation Aspiration System with Single Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55040. Labeled as Manufactured for Huntington Instruments, Ogden Utah.
Z-0021-04	Vital Concepts, Inc.	1	Irrigation Aspiration System with Double Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55060. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan. Huntington Instruments brand labeled as Manufactured for Huntington Instruments, Ogden Utah. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ. Catalogue # 55060-10 sold in Canada and labeled as Manufactured for Jac-Cell Medic, Dorval, Quebec.
Z-0022-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Irrigation Aspiration System with double Spike Tubing, no Probe, Disposable (single use only), sterile, latex free. Catalog # 55160. Vital Concepts, Inc., Grand Rapids, Michigan.
Z-0023-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Suction-Irrigation System without Probe, Disposable (single use only), sterile, latex free. R-Med Re-Order # 55170R; Distributed by R-Med, Inc., Orgeon, OH
Z-0024-04	Vital Concepts, Inc.	1	Quanta Technologies L.L.C. brand REORDER # LAPKIT 3. Contents 1 -55060 Suction/Irrigation Valve 2- 30012 Insufflation Tubing set 3- 5010 Anti Fog Solution with Sponge. Manufactured for Quanta Technologies, L.L.C., Tucson, AZ.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9613558. Last updated year: 2026. Please use registration number 9613558 when referencing this establishment in official correspondence.