BEUDAMED
    FDA Registration Active 🇫🇷 France

    OTIS implant - Height 7mm, Catalog Number P822365224

    Reg #: 3004549189 · FEI: 3004051158 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    20
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    SCIENCE & BIO MATERIALS, S.B.M. SAS
    Registration Number
    3004549189
    FEI Number
    3004051158
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    ZI DU MONGE
    City
    LOURDES Hautes-Pyrenees
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K071155

    Owner / Operator

    Firm Name
    SCIENCE & BIO MATERIALS
    Operator Number
    9063735
    Address
    S.B.M. SAS - ZI DU MONGE, --
    City
    Lourdes
    State
    Hautes-Pyrenees
    Postal Code
    65100
    Country
    FR
    Correspondent
    Anne - COSPIN

    US Agent

    Business Name
    Dawa Medical LLC
    Contact Name
    Stephan Toupin
    Address
    7320 NW 12th Street, Suite 103
    City
    Miami
    State
    FL
    ZIP
    33126
    Country
    US
    Email
    [email protected]
    Phone
    786 7311159

    Products

    Device Name Product Code
    Filler, Bone Void, Calcium Compound MQV

    Proprietary Names

    OTIS implant - Height 7mm, Catalog Number P822365224 OTIS implant - Height 9mm, Catalog Number P822365228 OTIS 50 implant - Height 14mm, Catalog Number P822667238 OTIS 50 implant - Height 13mm, Catalog Number P822667236 OTIS implant - Height 6mm, Catalog Number P822365222 OTIS implant - Height 10mm, Catalog Number P822365230 OTIS implant - Height 8mm, Catalog Number P822365226 OTIS 50 implant - Height 12mm, Catalog Number P822667234 OTIS 50 implant - Height 15mm, Catalog Number P822667240 OTIS 50 implant - Height 8mm, Catalog Number P822667226 OTIS implant - Height 13mm, Catalog Number P822365236 OTIS implant - Height 15mm, Catalog Number P822365240 OTIS 50 implant - Height 7mm, Catalog Number P822667224 OTIS implant - Height 12mm, Catalog Number P822365234 OTIS 50 implant - Height 6mm, Catalog Number P822667222 OTIS 50 implant - Height 11mm, Catalog Number P822667232 OTIS 50 implant - Height 9mm, Catalog Number P822667228 OTIS implant - Height 11mm, Catalog Number P822365232 OTIS 50 implant - Height 10mm, Catalog Number P822667230 OTIS implant - Height 14mm, Catalog Number P822365238

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device