BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    Xiros8315 (DV) -102-1082 Poly-Tape 20 mm x 800 mm; 102-1086 Poly-Tape 5 mm x 800 mm; 102-1087 Poly-Tape 7 mm x 800 mm

    Reg #: 3002807315 · FEI: 3002807315 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    SYNERGY HEALTH STERILISATION UK LTD
    Registration Number
    3002807315
    FEI Number
    3002807315
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Drayton Fields Industrial Estate, Brunel Close
    City
    Daventry Northamptonshire
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K222978

    Owner / Operator

    Firm Name
    STERIS Corporation
    Operator Number
    10042227
    Address
    5960 Heisley Road
    City
    Mentor
    State
    OH
    Postal Code
    44060
    Country
    US

    US Agent

    Business Name
    Synergy Health
    Contact Name
    Becky Aldhizer
    Address
    5960 Heisley Rd
    City
    Mentor
    State
    OH
    ZIP
    44060
    Country
    US
    Email
    [email protected]
    Phone
    440 3927490

    Products

    Device Name Product Code
    Mesh, Surgical, Polymeric FTL
    Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament QUW
    Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon OWX

    Proprietary Names

    Xiros8315 (DV) -102-1082 Poly-Tape 20 mm x 800 mm; 102-1086 Poly-Tape 5 mm x 800 mm; 102-1087 Poly-Tape 7 mm x 800 mm Xiros8315 (DV) - 102-1101 Infinity-Lock 5 mm x 400 mm; 102-1102 Infinity-Lock 7 mm x 400 mm Xiros8315 (DV) - 102-1005 Poly-Tape 5 mm x 500 mm; 102-1080 Poly-Tape 10 mm x 800 mm; 102-1081 Poly-Tape 15 mm x 800 mm; Xiros8315 (DV) - 102-1083 Poly-Tape 30 mm x 800 mm; 102-1143 AchilloCordPLUS

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)