Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004903580

FEI Number

3004903580

Entity Name

Johnson & Johnson do Brasil Ind. Com. de Prod. p/ Saude Ltda

City/State/Country

SAO JOSE DOS CAMPOS Sao Paulo, BR

Establishment Address

RODOVIA PRESIDENTE DUTRA, KM 154, SAO JOSE DOS CAMPOS Sao Paulo 12240-908, BR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

ETHICON INC. (Owner Number: 9068641)

Owner / Operator Contact Address

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

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

STRATAFIX Spiral PRONOVA Bidirectional Knotless Tissue Control Device STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device Vicryl Rapide Bone Wax

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	2026-05-05
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2011-05-04
MTJ	Wax, Bone	Unknown	Class U	N/A	2015-03-25

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
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
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

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 3004903580. Last updated year: 2026. Please use registration number 3004903580 when referencing this establishment in official correspondence.