Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013644499

FEI Number

3013644499

Entity Name

JOHNSON & JOHNSON DO BRASIL INDUSTRIA E COMERCIO DE PRODUTOS PARA SAUDE LTDA

City/State/Country

Guarulhos Sao Paulo, BR

Establishment Address

Avenue Julia Gaiolli, Number 740 - T300 Hangar 7 e 8 - Agua Chata, Guarulhos Sao Paulo 07251-500, BR

Establishment Type(s)

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

K843187

PMA Number

N/A

All Registered Proprietary Names

BONE WAX VICRYL RAPIDE Endoknot/Endoloop made with Coated Vicryl Endoknot/Endoloop made with PDS II Endoknot made with Ethibond Excel

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MTJ	Wax, Bone	Unknown	Class U	N/A	2007-05-03
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2011-11-09
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2011-12-15

Official Correspondent

Reynaldo Librojo

US Agent Details

Reynaldo Librojo Business: ETHICON INC. Email: RLibrojo@its.jnj.com Phone: (908) 8086028

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
3002294946	Johnson & Johnson MEDICAL GmbH	NORDERSTEDT Schleswig-Holstein, DE
3003702646	ETHICON SARL	NEUCHATEL, CH
3014272734	GMED Healthcare BVBA ( a Johnson & Johnson Company)	Courcelles Luxembourg, BE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K123940	Demetech Corp.	DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE	2014-05-30
K050845	ETHICON, Inc.	MONOCRYL PLUS ANTIBACTERIAL SUTURE	2005-06-29
K863293	Lifestream Int'L, Inc.	DISPOSABLE SUCTION CANNULA NO. 902008-000	1986-09-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 Undyed 18" P-10 Cutting, Product Number: SV9913, UDI: 20884521153278 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Z-0011-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" P-14 Cutting, Product Number: SV935, UDI: 20884521151755 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Z-0012-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-12 Cutting, Product Number: SV426, UDI: 20884521151731 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Z-0013-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" KV-34 TaperCutting, Product Number: CV919, UDI: 20884521151649 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Z-0014-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" C-12 Cutting, Product Number: SV2294, UDI 20884521151403 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013644499. Last updated year: 2026. Please use registration number 3013644499 when referencing this establishment in official correspondence.