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    FDA Registration Active 🇺🇸 United States

    GP-035EP - GUTTA PERCHA 35 PACKAGED ENDODENT MATERIAL (CALG202)

    Reg #: 3017604 · FEI: 3017604 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    16
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    ASEPTICO, INC.
    Registration Number
    3017604
    FEI Number
    3017604
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    8333 216th St SE
    City
    WOODINVILLE
    State
    WA
    ZIP
    98072
    Country
    US

    Owner / Operator

    Firm Name
    ASEPTICO, INC.
    Operator Number
    3017604
    Address
    8333 216TH ST., S.E., --
    City
    Woodinville
    State
    WA
    Postal Code
    98072
    Country
    US

    Products

    Device Name Product Code
    Gutta-Percha EKM

    Proprietary Names

    GP-035EP - GUTTA PERCHA 35 PACKAGED ENDODENT MATERIAL (CALG202) GP-035SP - GUTTA PERCHA 35 PACKAGED CARTRIDGE STANDARD FILL MATERIAL (CALG20) GP-025SP-MF - GUTTA PERCHA 25 MAILLEFER / 23G GP-025EP - GUTTA PERCHA 25 PACKAGED ENDODENT MATERIAL (CALG232) GP-018E20P - GUTTA PERCHA 18 PACKAGED CARTRIDGE EASY FLOW MATERIAL (CALG25) GP-018E20P-VDW - GUTTA PERCHA 18 FOR VDW PACKAGED-EASY FLOW FILL MATERIAL GP-035SP-VDW - GUTTA PERCHA 35 FOR VDW PACKAGED-STANDARD FILL MATERIAL GP-035CP-ROW - GUTTA PERCHA 35 PACKAGED CARTRIDGE FOR AEU-65-ROW GP-035SP-MF - GUTTA PERCHA 35 MAILLEFER / 20G GP-025CP-ROW - GUTTA PERCHA 25 PACKAGED CARTRIDGE FOR AEU-65-ROW GP-018CP-ROW - GUTTA PERCHA 18 PACKAGED CARTRIDGE FOR AEU-65-ROW GP-035CP-DS - GUTTA PERCHA 35 PACKAGED CARTRIDGE FOR AEU-65-DS GP-025SP-VDW - GUTTA PERCHA 25 FOR VDW PACKAGED-STANDARD FILL MATERIAL GP-018CP-DS - GUTTA PERCHA 18 PACKAGED CARTRIDGE FOR AEU-65-DS GP-025SP - GUTTA PERCHA 25 PACKAGED CARTRIDGE STANDARD FILL MATERIAL (CALG23) GP-025CP-DS - GUTTA PERCHA 25 PACKAGED CARTRIDGE FOR AEU-65-DS

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)