BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGEN

    Reg #: 1216032 · FEI: 1216032 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Citra Labs LLC
    Registration Number
    1216032
    FEI Number
    1216032
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    55 Messina Dr
    City
    Braintree
    State
    MA
    ZIP
    02184
    Country
    US

    Regulatory Submissions

    510(k) Number
    K101557

    Owner / Operator

    Firm Name
    Biomet, Inc.
    Operator Number
    1825034
    Address
    56 East Bell Dr., PO Box 587
    City
    Warsaw
    State
    IN
    Postal Code
    46582
    Country
    US

    Products

    Device Name Product Code
    Filler, Bone Void, Calcium Compound MQV
    Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) MBP

    Proprietary Names

    GAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGEN

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)