BEUDAMED
    FDA Registration Active 🇧🇷 Brazil

    ORTOFACE COSMETICOS E PRODUTOS PARA SAUDE LTDA

    Reg #: 3043620689 · FEI: 3043620689 · Expires 2026
    View on FDA
    Products
    21
    Proprietary Names
    23
    Establishment Types
    1
    Classifications
    21

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    Registration Details

    Registration Name
    ORTOFACE COSMETICOS E PRODUTOS PARA SAUDE LTDA
    Registration Number
    3043620689
    FEI Number
    3043620689
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Rua Rodrigues Alves, 505, Centro
    City
    Salto Sao Paulo
    Country
    BR

    Regulatory Submissions

    510(k) Number
    K250559

    Owner / Operator

    Firm Name
    GM dos Reis Industria e Comercio Ltda
    Operator Number
    10059832
    Address
    Avenida Pierre Simon de La Place, 600
    City
    Campinas
    State
    Sao Paulo
    Postal Code
    13069320
    Country
    BR
    Correspondent
    Paula Oliveira

    Products

    Device Name Product Code
    Orthopedic Manual Surgical Instrument LXH
    Rod, Fixation, Intramedullary And Accessories HSB
    Cerclage, Fixation JDQ
    Burr, Orthopedic HTT
    Screw, Fixation, Bone HWC
    Condylar Plate Fixation Implant JDP
    Plate, Fixation, Bone HRS
    Instrument, Ligature Passing And Knot Tying HCF
    Accessories, Arthroscopic NBH
    Template HWT
    Thoracolumbosacral Pedicle Screw System NKB
    Tray, Surgical, Instrument FSM
    Extractor HWB
    Washer, Bolt Nut HTN
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment KIJ
    Passer HWQ
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Instrument, Manual, Surgical, General Use MDM
    Kit, Surgical Instrument, Disposable KDD

    Proprietary Names

    Orthopedic manual surgical instruments Percutaneous Foot Burrs, GMREIS Arthodesis Burrs, GMREIS STA - ACHILLES TENDON SUTURE SYSTEM 312-500 - MULTICUTTER - Arthroscopic Retrograde Drill 359-210 - ACCESS FIT – RIGHT SUTURE PASSER 335-200 - MICRO EASYPASS - SMALL CURVED MICRO SUTURE PASSER 335-100 - MICRO EASYPASS - STRAIGHT MICRO SUTURE PASSER 335-99 - MICRO EASYPASS - SHORT CURVED MICRO SUTURE PASS 335-300 - MICRO EASYPASS - LARGE CURVED MICRO SUTURE PASSER 359-200 - ACCESS FIT – STRAIGHT SUTURE PASSER 359-220 - ACCESS FIT – LEFT SUTURE PASSER 335-600 - MICRO EASYPASS - EXTRA LARGE CURVED MICRO SUTURE PASSER TEMPLATE Tray, Surgical, Instrument Screw Removal Kit Meniscus Versaflex Minidriver Solaris Suture Fisher Suture Passer INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT 354-100-050 - Meniscus Suture - OUT IN Surgical instrument

    Establishment Types

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