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    FDA Registration Active 🇬🇧 United Kingdom

    DUP31622-9 (US Market) - Borderless Medihoney HCS

    Reg #: 9680731 · FEI: 3002265219 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    19
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    FIRST WATER RAMSBURY LTD
    Registration Number
    9680731
    FEI Number
    3002265219
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Hilldrop Lane, Ramsbury
    City
    Marlborough Wiltshire
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K110546

    Owner / Operator

    Firm Name
    GENTELL
    Operator Number
    10026501
    Address
    180 Rittenhouse Circle,
    City
    Bristol
    State
    PA
    Postal Code
    19007
    Country
    US
    Correspondent
    Michael Alford

    US Agent

    Business Name
    GENTELL LLC
    Contact Name
    MICHAEL ALFORD
    Address
    1000 Floral Vale Blvd Ste 400
    City
    Morrisville
    State
    PA
    ZIP
    19067
    Country
    US
    Email
    [email protected]
    Phone
    800 8409041

    Products

    Device Name Product Code
    Dressing, Wound, Drug FRO

    Proprietary Names

    DUP31622-9 (US Market) - Borderless Medihoney HCS DUP31612-9 (US Market) - Borderless Medihoney HCS DUP31644-9 (US Market) - Borderless Medihoney HCS CVS31631-9 HCS CVS Honey Pad Small 1.8" x 3" DUP787-9 - Medihoney HCS Surgical DUP31744-9 (US Market) - Bordered Medihoney HCS CVS31723-9 CVS MH Burn DUP31722-9 (US Market) - Bordered Medihoney HCS CVS31684-9 - Medihoney CVS Large CVS31632-9 - Medihoney CVS Small DUP31688-9 (US Market) - Borderless Medihoney HCS CVSP5LB301-9 - CVS Manuka Honey Adhesive Strip Manuka Spot Bandage CVS7768-9 DUP31738-9 - Medihoney HCS Surgical Honey Hydrogel Sheet Dressing 2.4"x2.4",7"x5",4.3"x3.4" COM31632-9 - Comvita CVS31685-9 - Medihoney CVS Large CVS31722-9 CVS MH Woundcare

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)