Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008483449

FEI Number

3008483449

Entity Name

MEDISUT, S.A.

City/State/Country

Managua, NI

Establishment Address

Km 12.5 Carretera Norte Edificio 4A, Corporacion de Zona Francas Las Mercedes, Managua 10000, NI

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Medisut, S.A. (Owner Number: 10051008)

Owner / Operator Contact Address

Km 12.5 Carretera Norte Edificio 4A, Corporacion de Zona Francas Las Mercedes, Managua, NI-MN 10000, NI

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Nylon Suture Silk Suture Natural Suture Polypropylene Suture

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GAR	Suture, Nonabsorbable, Synthetic, Polyamide	General, Plastic Surgery	Class 2	878.5020	2016-01-25
GAP	Suture, Nonabsorbable, Silk	General, Plastic Surgery	Class 2	878.5030	2016-01-25
GAL	Suture, Absorbable, Natural	General, Plastic Surgery	Class 2	878.4830	2016-01-25
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	2016-01-25

Official Correspondent

Alejandro Salinas

US Agent Details

ALEXANDER S. ORLOFSKY Business: THE ORLOFSKY LAW FIRM P.L. Email: alex@orlofskylawfirm.com Phone: (305) 5382344

Related Public Records

Same Entity

Medisut, S.A.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K241486	Covidien	Sofsilk Coated Braided Silk Suture	2024-12-03

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0034-2009	Surgical Specialties Corp	2	3-0 Black Mono Nylon Suture, 12 units per box. product number 925B. The product intended for use in general soft tissue approximation and/or ligation including use in ophthalmic procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008483449. Last updated year: 2026. Please use registration number 3008483449 when referencing this establishment in official correspondence.