BEUDAMED
    FDA Registration Active 🇫🇷 France

    BIO 1 Cubes for filling - 7 x 7 x 7 mm (2.40 cm3), Catalog Number P822693426

    Reg #: 3004549189 · FEI: 3004051158 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    45
    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
    K021963

    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

    BIO 1 Cubes for filling - 7 x 7 x 7 mm (2.40 cm3), Catalog Number P822693426 BIO 1 Block for filling - 10x10x25 mm (5 cm3), Catalog Number P822694446 BIO 1 Cubes for filling - 5 x 5 x 5 mm (0.62 cm3), Catalog Number P822693221 BIO 1 Sticks for filling - 5 x 5 x 20 mm (2.5 cm3), Catalog Number P822634443 BIO 1 Cubes for filling - 7 x 7 x 7 mm (1.71 cm3), Catalog Number P822693422 BIO 1 Granules for filling - ø 3 mm (5 cm3), Catalog Number P822692644 BIO 1 Granules for filling - ø 1,5 mm (5 cm3), Catalog Number P822692444 BIO 1 Cubes for filling - 10 x 10 x 10 mm (1 cm3), Catalog Number P822693620 BIO 1 Cubes for filling - 7 x 7 x 7 mm (0.34 cm3), Catalog Number P822693420 BIO 1 Granules for filling - ø 1,5 mm (15 cm3), Catalog Number P822692446 BIO 1 Sticks for filling - 5 x 5 x 20 mm (0.5 cm3), Catalog Number P822634446 BIO 1 Cubes for filling - 5 x 5 x 5 mm (1.25 cm3), Catalog Number P822693222 BIO 1 Granules for filling - ø 3 mm (5 cm3), Catalog Number P822692645 BIO 1 Granules for filling - ø 3 mm (45 cm3), Catalog Number P822692652 BIO 1 Granules for filling - ø 1 mm (2 cm3), Catalog Number P822692243 BIO 1 Sticks for filling - 5 x 5 x 20 mm (5 cm3), Catalog Number P822634444 BIO 1 Cubes for filling - 5 x 5 x 5 mm (7.5 cm3), Catalog Number P822693227 BIO 1 Block for filling - 10x10x25 mm (2,5 cm3), Catalog Number P822694444 BIO 1 Cubes for filling - 10 x 10 x 10 mm (5 cm3), Catalog Number P822693623 BIO 1 Macro-porous cubes for filling - 4 x 4 x 4 mm (45 cm3), Catalog Number P822893232 BIO 1 Cubes for filling - 5 x 5 x 5 mm (2.5 cm3), Catalog Number P822693225 BIO 1 Cylinder for filling - ø 8 mm / L 10 mm, Catalog Number P822661222 BIO 1 Macro-porous cubes for filling - 4 x 4 x 4 mm (15 cm3), Catalog Number P822893229 BIO 1 Sticks for filling - 5 x 5 x 20 mm (10 cm3), Catalog Number P822634445 BIO 1 Granules for filling - ø 1 mm (15 cm3), Catalog Number P822692246 BIO 1 Granules for filling - ø 3 mm (15 cm3), Catalog Number P822692648 BIO 1 Sticks for filling - 5 x 5 x 10 mm (5 cm3), Catalog Number P822634441 BIO 1 Granules for filling - ø 3 mm (10 cm3), Catalog Number P822692647 BIO 1 Granules for filling - ø 1 mm (0.6 cm3), Catalog Number P822692240 BIO 1 Granules for filling - ø 1,5 mm (5 cm3), Catalog Number P822692445 BIO 1 Cylinder for filling - ø 5.6 mm / L 25 mm, Catalog Number P822441444 BIO 1 Cubes for filling - 10 x 10 x 10 mm (10 cm3), Catalog Number P822693624 BIO 1 Granules for filling - ø 1,5 mm (15 cm3), Catalog Number P822692448 BIO 1 Granules for filling - ø 3 mm (15 cm3), Catalog Number P822692646 BIO 1 Cubes for filling - 5 x 5 x 5 mm (0.25 cm3), Catalog Number P822693220 BIO 1 Cubes for filling - 7 x 7 x 7 mm (0.69 cm3), Catalog Number P822693421 BIO 1 Cubes for filling - 10 x 10 x 10 mm (2 cm3), Catalog Number P822693622 BIO 1 Sticks for filling - 5 x 5 x 10 mm (2.5 cm3), Catalog Number P822634442 BIO 1 Granules for filling - ø 1 mm (5 cm3), Catalog Number P822692244 BIO 1 Sticks for filling - 5 x 5 x 10 mm (1.25 cm3, Catalog Number P822634440 BIO 1 Cubes for filling - 10 x 10 x 10 mm (15 cm3), Catalog Number P822693626 BIO 1 Cylinder for filling - ø 5.6 mm / L 25 m, Catalog Number P822441442 BIO 1 Sticks for filling - 3 x 3 x 10 mm (0.9 cm3), Catalog Number P822634240 BIO 1 Cubes for filling - 5 x 5 x 5 mm (0.12 cm3), Catalog Number P822693210 BIO 1 Cubes for filling - 7 x 7 x 7 mm (7.20 cm3), Catalog Number P822693428

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device