Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016761372

FEI Number

3016761372

Entity Name

Medline Panama LLC S. de R.L.

City/State/Country

Veracruz, Arraijan Panama, PA

Establishment Address

Panama-Pacifico, Boulevard Panama Pacifico, International Business Park, Building 3855, Office 209, Veracruz, Arraijan Panama 1001, PA

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Medline Industries, LP (Owner Number: 1417592)

Owner / Operator Contact Address

Three Lakes Drive, Northfield, IL 60093, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K190950

PMA Number

N/A

All Registered Proprietary Names

Gemini Medline Medline

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2022-11-07
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2008-11-20
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2008-11-20
MMP	Cover, Barrier, Protective	General, Plastic Surgery	Class 2	878.4370	2010-11-10
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-10-16

Official Correspondent

Stephanie Augsburg

US Agent Details

Rosanna Lee Business: Simcon International LLC Email: rlee@simconintl.com Phone: (847) 9492290

Related Public Records

Same Entity

Medline Industries, LP

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007128716	Medline Industries, LP	Norristown, PA, US
3036706541	EXCELSIOR MEDICAL LLC	Tinton Falls, NJ, US
3016073670	Medline Logistics Japan G.K.	Nishihocho, Aisai-shi Aichi, JP
3006581049	MICROTEK MEDICAL MALTA LIMITED	Mosta, MT
3010389834	Microtek Medical B.V. Varsseveld	VARSSEVELD Gelderland, NL

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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9680031	STEPAC L.A., LTD.	TEFEN, WESTERN GALILEE Northern, IL
9616096	La Ada de Acuna	CIUDAD DE ACUNA Coahuila, MX
1054380	Halyard North Carolina, LLC	LINWOOD, NC, US
8030674	ESPECIALISTAS EN ESTERILIZACION Y ENVASE, S. A. DE C. V.	Tlalnepantla, Estado de Mexico, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016761372. Last updated year: 2026. Please use registration number 3016761372 when referencing this establishment in official correspondence.