BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    CWL 1006 - KerraLite Cool

    Reg #: 9680731 · FEI: 3002265219 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    53
    Establishment Types
    3
    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

    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, Hydrogel Without Drug And/Or Biologic NAE

    Proprietary Names

    CWL 1006 - KerraLite Cool 73231-00 - Cutimed Hydrocontrol 40-2979 - Hydrogel Dressing 53048 Aquasite Impregnated Gauze Size 4" x 8" DUP86322-9 Xtrasorb HCS 2.3"x2.3" DUP81110 Aquasite Amorphous Hydrogel Dressings 1 fl oz Bellows GEN-11240 Gentell Hydrogel Sheet Dressing Borderless 2.4” x 2.4” (6cm x 6cm) Lansinoh C-Section Hydrogel Pads BSN7261000- Cutimed Hydrogel 8 grams tube w/applicator Curad “Soothe & Cool” Dressing (56 x 26mm) 6030-4157 - Glaciergel CWL 1004 - KerraLite Cool ZGIH44 HYDROGEL IMPREGNATED GAUZE DRESSING 4"X 4" Reliamed 6030-4156 - Glaciergel DH-03 Dermagran Hydrogel Wound Dressing 3oz Medela Breast Pads (USA) CVS86433-9 Xtrasorb HCS Non-Adhesive 3"x3" (cvs) BSN7261001- Cutimed Hydrogel 15 grams tube w/applicator CWL 1007 - KerraLite Cool Border BSN7261003- Cutimed Hydrogel 15 grams tube CWL 1008 - KerraLite Cool Border 73231-02 - Cutimed Hydrocontrol 53022 Aquasite Impregnated Gauze Size 2" x 2" GEN-11700 Gentell Hydrogel Sheet Dressing Borderless 7” x 5” (17.8cm x 12.7cm) 73230-02 - Leukomed Control Russell Chest Seal CWL 1009 - KerraLite Cool Border 73231-01 - Cutimed Hydrocontrol DUP53044 Aquasite Impregnated Gauze Size 4" x 4" 73230-01 - Leukomed Control 61-53044 HYDROGEL IMPREGNATED GAUZE DRESSING 4"X 4" MCKESSON 81110 HYDROGEL WOUND DRESSING 1 FL.OZ. MCKESSON 73230-05 - Leukomed Control 73230-00 - Leukomed Control CBL-0808-118 8"X 8" FOAM DRESSING CBL-0206- 118 2"X 6" FOAM DRESSING 73230-03 - Leukomed Control DUP86344-9 Xtrasorb HCS 4.5"x4.5" CVS53022-4 CVS MOIST COOLING BURN PAD 2" X 2" 73231-03 - Cutimed Hydrocontrol BSN7261002- Cutimed Hydrogel 25 grams tube w/applicator 61-53022 HYDROGEL IMPREGNATED GAUZE DRESSING 2"X 2" MCKESSON GEN-11470 Gentell Hydrogel Sheet Dressing Borderless 4.7” x 3.4” (12cm x 8.6cm) DUP81144 Aquasite Hydrogel Impregnated Non-Woven Dressing 2" x 2" CWL 1005 - KerraLite Cool DUP86466-9 - Xtrasorb HCS Adhesive Curad “Soothe & Cool” Dressing (74 x 45mm) DUP81122 Aquasite Hydrogel Impregnated Non-Woven Dressing 2" x 2" CBL-1212-118 12"X12" FOAM DRESSING CBL-0404 - 118 4"X 4" FOAM DRESSING DUP53048 Aquasite Impregnated Gauze Size 4" x 8" DUP86433-9 - Xtrasorb HCS Non-Adhesive DUP86388-9 - Xtrasorb HCS Non-Adhesive

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device