BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    2.7MM 30° C-MOUNT, STUBBY

    Reg #: 8010418 · FEI: 3007130719 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    90
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    HENKE-SASS WOLF, GMBH.
    Registration Number
    8010418
    FEI Number
    3007130719
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    KELTENSTRASSE 1
    City
    TUTTLINGEN Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K093677

    Owner / Operator

    Firm Name
    HENKE-SASS WOLF, GMBH.
    Operator Number
    8010418
    Address
    Keltenstrasse 1, --
    City
    TUTTLINGEN
    State
    Baden-Wurttemberg
    Postal Code
    D-78532
    Country
    DE
    Correspondent
    MICHAEL - HERZOG

    US Agent

    Business Name
    HENKE-SASS, WOLF OF AMERICA
    Contact Name
    Loretta MCHUGH
    Address
    135 SCHOFIELD AVENUE
    City
    Dudley
    State
    MA
    ZIP
    01571
    Country
    US
    Email
    [email protected]
    Phone
    508 6719356

    Products

    Device Name Product Code
    Arthroscope HRX

    Proprietary Names

    2.7MM 30° C-MOUNT, STUBBY HD 2.7MM X 0° ARTHROSCOPE SPEEDLOCK A/C 4MM 30° AUTOCLAVABLE ARTHROSCOPE, C-MOUNT 4MM 30° AUTOCLAVABLE REVERSE CANT ARTHROSCOPE, C-MOUNT 2.7MM STUBBY SCOPE AUTOCLAVABLE 2.3MM X 0 DEG, C-,MOUNT, A/C 1.9MM X 30º C-MOUNT, A/C HD 4MM X 30° REVERSE CANT ARTHROSCOPE SPEEDLOCK A/C 2.3MM X 30 DEG, C-,MOUNT, A/C HD 4MM X 70 DEG LONG ARTHROSCOPE, SPEEDLOCK, C-MOUNT, A/C 2.3MM X 0 DEG, A/C 2.7MM 0 DEG AUTOCLAVABLE ARTHROSCOPE HD 2.3MM X 30° REVERSE CANT ARTHROSCOPE J-LOCK A/C 4MM 70° C-MOUNT STYLE A ARTHROSCOPE HD 2.7MM X 30 DEGREE ARTHROSCOPE, SPEEDLOCK, C-MOUNT, A/C 2.7MM 70° A/C STUBBY ARTHROSCOPE WITH SPEED-LOCK, C-MOUNT HD 4MM X 0° ARTHROSCOPE, SPEEDLOCK, C-MOUNT 4MM 70° LONG AUTOCLAVABLE ARTHROSCOPE, 16.5 CM 2.7MM 70 DEG AUTOCLAVABLE ARTHROSCOPE HD 4MM X 30° REVERSE CANT LONG ARTHROSCOPE, SPEEDLOCK, C-MOUNT, A/C 2.7MM 0° C-MOUNT, STUBBY HD 2.7MM X 0 DEGREE STUBBY ARTHROSCOPE, J-LOCK, C-MOUNT, A/C 1.9MM 30° NON-AUTOCLAVABLE ARTHROSCOPE W/SPEEDLOCK, C-MOUNT 2.3MM X 30 DEG, A/C 4MM 30° AUTOCLAVABLE HIP ARTHROSCOPE 4MM 0° LONG AUTOCLAVABLE ARTHROSCOPE, 16.5CM 2.7MM 30° NON-A/C STUBBY ARTHROSCOPE W/SPEEDLOCK, C-MOUNT HD 2.7MM X 70° STUBBY ARTHROSCOPE J-LOCK A/C HD 2.7MM X 30 DEGREE REVERSE CANT STUBBY ARTHROSCOPE, J-LOCK, C-MOUNT, A/C HD 1.9MM X 30° ARTHROSCOPE J-LOCK A/C 2.3MM X 70 DEG, C-,MOUNT, A/C 4MM 70° AUTOCLAVABLE ARTHROSCOPE, C-MOUNT HD 2.3MM X 0° ARTHROSCOPE J-LOCK A/C 2.3MM 30° NON-AUTOCLAVABLE ARTHROSCOPE W/SPEEDLOCK,C-MOUNT HD 4MM X 45° ARTHROSCOPE, SPEEDLOCK, A/C 4MM 30° C-MOUNT STYLE A ARTHROSCOPE HD 4MM X 30° LONG ARTHROSCOPE, SPEEDLOCK, C-MOUNT, A/C HD 2.7MM X 70 DEGREE ARTHROSCOPE, SPEEDLOCK, C-MOUNT, A/C 2.7MM X 30° STUBBY AUTOCLAVABLE STUBBY SCOPE REVERSE CANT HD 2.3MM X 0 DEGREE ARTHROSCOPE, J-LOCK, C-MOUNT, A/C 4MM X 0° LONG ARTHROSCOPE SPEEDLOCK A/C 4MM 30° LONG AUTOCLAVABLE ARTHROSCOPE, 16.5CM HD 2.7MM X 0 DEGREE ARTHROSCOPE, SPEEDLOCK, C-MOUNT, A/C HD 2.7MM X 30° ARTHROSCOPE SPEEDLOCK A/C HD 1.9 X 0 DEGREE ARTHROSCOPE, J-LOCK, C-MOUNT, A/C 4MM X 70° LONG ARTHROSCOPE SPEEDLOCK A/C HD 2.3MM X 30 DEGREE REVERSE CANT ARTHROSCOPE, J-LOCK, C-MOUNT, A/C 4MM AUTOCLAVABLE ARTHROSCOPE HD 70 DEG., ARTHROSCOPE, 4MM X 165MM, C-MOUNT, SPEEDLOCK, A/C HD 2.3MM X 70° ARTHROSCOPE J-LOCK A/C HD 2.7MM X 30 DEGREE STUBBY ARTHROSCOPE, J-LOCK, C-MOUNT, A/C IDEAL EYES PRECISION HD, 4MM, 0 DEG., AUTOCLAVABLE ARTHROSCOPE, C-MOUNT, 140MM, SPEEDLOCK 4MM 0° C-MOUNT STYLE A ARTHROSCOPE PKG, 1.9MM TMJ, AUTOCLAVABLE IDEAL EYES 30° ARTHROSCOPE, 2.9 X 200 MM, EYEPIECE, SPEED-LOCK, AUTOCLAVABLE (SPA EYEPIECE SCOPE) 2.7MM 30°C-MOUNT, ARTHROSCOPE HD 4MM X 30° ARTHROSCOPE SPEEDLOCK A/C HD 2.7MM X 0° STUBBY ARTHROSCOPE J-LOCK A/C 2.7MM 30° AUTOCLAVABLE ARTHROSCOPE WITH SPEED-LOCK, C-MOUNT HD 4MM X 70° ARTHROSCOPES, SPEEDLOCK, A/C 4MM A/C ARTHROSCOPE HD 4MM X 0° ARTHROSCOPE SPEEDLOCK A/C HD 2.3MM X 30 DEGREE ARTHROSCOPE, J-LOCK, C-MOUNT, A/C 2.7MM X 0 DEG, C-MOUNT, A/C HD 4MM X 30° ARTHROSCOPE, SPEEDLOCK, C-MOUNT, A/C 2.7MM 0° C-MOUNT, ARTHROSCOPE HD 1.9MM X 0° ARTHROSCOPE J-LOCK A/C HD 2.7MM X 70 DEGREE STUBBY ARTHROSCOPE, J-LOCK, C-MOUNT, A/C IDEAL EYES PRECISION HD, 4MM, 30 DEG., AUTOCLAVABLE ARTHROSCOPE, C-MOUNT, 140MM, REVERSE CANT, SPEEDLOCK IDEAL EYES PRECISION HD, 4MM, 70 DEG., AUTOCLAVABLE ARTHROSCOPE, C-MOUNT, 140MM, SPEEDLOCK HD 30 DEG., 4MM X 165MM, C-MOUNT, SPEEDLOCK, A/C 4MM X 30° LONG ARTHROSCOPE SPEEDLOCK A/C 2.7MM X 30 DEG, C-MOUNT, A/C HD 2.3MM X 70 DEGREE ARTHROSCOPE, J-LOCK, C-MOUNT, A/C 4MM 0DEG C-MOUNT HD 1.9MM X 30 DEGREE ARTHROSCOPE, J-LOCK, C-MOUNT, A/C 2.7MM 0° NON-A/C STUBBY ARTHROSCOPE W/SPEEDLOCK, C-MOUNT HD 4MM X 70° ARTHROSCOPE, SPEEDLOCK, C-MOUNT, A/C 2.3MM X 30 DEG, C-,MOUNT, REVERSE CANT, A/C 4MM 0° AUTOCLAVABLE ARTHROSCOPE, C-MOUNT HD 30 DEG, ARTHROSCOPE, 4MM X 165MM, C-MOUNT, SPEEDLOCK, A/C, REVERSE CANT 2.7MM 30 DEG AUTOCLAVABLE ARTHROSCOPE HD 4MM X 30° REVERSE CANT ARTHROSCOPE, SPEEDLOCK, C-MOUNT, A/C 4MM 70° AUTOCLAVABLE HIP ARTHROSCOPE 2.7MM X 70DEG STUBBY, A/C 2.9MM IDEAL EYES PRECISION HD AUTOCLAVABLE 200MM C-MOUNT ARTHROSCOPE - 30 DEG. WITH MODIFIED SPEEDLOCK HD 2.7MM X 30° STUBBY ARTHROSCOPE J-LOCK A/C HD 2.7MM X 70° ARTHROSCOPE SPEEDLOCK A/C HD 2.3MM X 30° ARTHROSCOPE J-LOCK A/C IDEAL EYES PRECISION HD, 4MM, 30 DEG., AUTOCLAVABLE ARTHROSCOPE, C-MOUNT, 140MM, SPEEDLOCK

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)