Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011497662

FEI Number

3011497662

Entity Name

Vidales Larranaga SA de CV

City/State/Country

Ahuachapan, SV

Establishment Address

Calle Los Coroneles 1, Colonia San Rafael, Ahuachapan 2101, SV

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

ICAT S.A. de C.V. (Owner Number: 10040106)

Owner / Operator Contact Address

KM 12.5 Carretera Troncal del Norte, Apopa, San Salvador, SV-SS 00000, SV

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

STC ID Code NA1 NA3 NB1 NB3 ComPel Surgical Drapes ProTexa L2 Surgical Gown STC ID Code NG7 ComPel MLR Surgical Gown PB70 STC ID Product Codes AG8 Examination Apparel and Xray Gowns STC ID Code NG3 NG5 ComPel XTR Surg Gowns George Courey Inc STC ID Code NG9 NH0 Promax Combosafe Surgical Gowns PB70 Barrier Supreme Sterilization Wrapper STC ID Product Codes CAA, CAO, CA1 - CA10, MD1, SZ1 Underpads, Drawsheets, Mattress Covers STC ID Product Codes AB1, AB Non Surgical Gowns and Cover Gowns STC ID Code NA1 NA3 NB1 NB3 Promax Surgical Drapes and Covers STC ID Code ND1 ND2 Wrappel Wrappers MEDLINE INDUSTRIES, LP - Northfield

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2015-11-06
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2025-01-23
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2015-11-06
FME	Gown, Examination	General Hospital	Class 1	880.6265	2012-03-08
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2025-04-21
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2015-11-06
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2025-09-18
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2015-11-06
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2018-04-09
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2025-04-21
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2025-04-21
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2025-04-21
FMW	Cover, Mattress (Medical Purposes)	General Hospital	Class 1	880.6190	2013-03-14
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2012-03-08
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2015-11-06
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2015-11-06
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2025-04-21
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2025-11-21

Official Correspondent

Miguel Sandoval

US Agent Details

Tim Wirring Email: twirrig@standardtextile.com Phone: (513) 7619255

Related Public Records

Same Entity

ICAT S.A. de C.V.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3005748481	ICAT S.A. DE C.V.	San Salvador, SV

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
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
K892118	Paramount Products, Inc.	NON-STERILE MASKS AND CAPS	1989-04-20

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1836161	ASPEN SURGICAL PRODUCTS, INC.	Caledonia, MI, US
2022435	Sterigenics U.S., LLC	Tustin, CA, US
2648727	CUSTOMED, INC.	Fajardo, PR, US
1061124	Sterigenics U.S., LLC	Charlotte, NC, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011497662. Last updated year: 2026. Please use registration number 3011497662 when referencing this establishment in official correspondence.