Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005625540

FEI Number

3005625540

Entity Name

FABRICA DE ARTEFATOS METALURGICOS ITA LTDA

City/State/Country

Sao Caetano do Sul Sao Paulo, BR

Establishment Address

Al. Sao Caetano 2790, Sao Caetano do Sul Sao Paulo 09560-500, BR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

FABRICA DE ARTEFATOS METALURGICOS ITA LTDA (Owner Number: 10089885)

Owner / Operator Contact Address

Al. Sao Caetano 2790, São Caetano do Sul, BR-SP 09560-500, BR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

FAMI Processing Basket Accessories FAMI Processing Basket

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2024-01-18

Official Correspondent

Alexandre Nardi

US Agent Details

Rodrigo Abreu Business: United Regulatory & Logistics LLC Email: info@unitedregulatory.com Phone: (786) 2667900

Related Public Records

Same Entity

FABRICA DE ARTEFATOS METALURGICOS ITA LTDA

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
K881095	CooperVision, Inc.	KOI(TM) INSTRUMENT TRAYS	1988-04-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0036-2010	Alphatec Spine, Inc.	1	ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.

Similar Registrations

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1646747	WEXLER SURGICAL, INC.	HOUSTON, TX, US
1037577	ANGIOSYSTEMS, INC.	DUCKTOWN, TN, US
3016171961	HANGZHOU ALLINE PLASTIC CO., LTD.	HANGZHOU Zhejiang, CN
3007485169	MEDYSSEY CO., LTD.	Jecheon-si Chungbuk, KR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005625540. Last updated year: 2026. Please use registration number 3005625540 when referencing this establishment in official correspondence.