Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3032543753

FEI Number

3032543753

Entity Name

Ethicon LLC

City/State/Country

Alts de Manati, PR, US

Establishment Address

PR-2, Km 45.6, Alts de Manati, PR 00674, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ETHICON INC. (Owner Number: 2210968)

Owner / Operator Contact Address

1000 US Highway 202 S., Raritan, NJ 08869, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K133356

PMA Number

N/A

All Registered Proprietary Names

PROLENE Polypropylene Nonabsorbable Suture

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	2013-12-11

Official Correspondent

Reynaldo Librojo

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ETHICON 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
3023251262	GATT Technologies BV	Nijmegen Gelderland, NL
3004903580	Johnson & Johnson do Brasil Ind. Com. de Prod. p/ Saude Ltda	SAO JOSE DOS CAMPOS Sao Paulo, BR
3013644499	JOHNSON & JOHNSON DO BRASIL INDUSTRIA E COMERCIO DE PRODUTOS PARA SAUDE LTDA	Guarulhos Sao Paulo, BR
3002294946	Johnson & Johnson MEDICAL GmbH	NORDERSTEDT Schleswig-Holstein, DE
3003702646	ETHICON SARL	NEUCHATEL, CH

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3032543753. Last updated year: 2026. Please use registration number 3032543753 when referencing this establishment in official correspondence.