BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GEM 21S® Growth-Factor Enhanced Matrix

    Reg #: 3007884119 · FEI: 3007884119 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Altasciences CDMO Philadelphia, LLC
    Registration Number
    3007884119
    FEI Number
    3007884119
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1510 Delp Drive, 1508 Delp Drive
    City
    Harleysville
    State
    PA
    ZIP
    19438
    Country
    US

    Regulatory Submissions

    PMA Number
    P040013

    Owner / Operator

    Firm Name
    Altasciences CDMO Philadelphia, LLC
    Operator Number
    10059529
    Address
    1510 Delp Drive
    City
    Harleysville
    State
    PA
    Postal Code
    19438
    Country
    US
    Correspondent
    Meghan Rollison

    Products

    Device Name Product Code
    Biologic Material, Dental NQA
    Bone Grafting Material, Dental, With Biologic Component NPZ

    Proprietary Names

    GEM 21S® Growth-Factor Enhanced Matrix

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)