BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FLEXIKOLD STANDARD COLD PACK

    Reg #: 3005621376 · FEI: 3005621376 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    52
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    POLYGEL LLC.
    Registration Number
    3005621376
    FEI Number
    3005621376
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1 Danforth Drive
    City
    Palmer TWP
    State
    PA
    ZIP
    18045
    Country
    US

    Owner / Operator

    Firm Name
    POLYGEL LLC.
    Operator Number
    9080190
    Address
    1 Danforth Dr., --
    City
    Palmer
    State
    PA
    Postal Code
    18045
    Country
    US
    Correspondent
    LAWRENCE - KERSEN

    Products

    Device Name Product Code
    Pack, Hot Or Cold, Reusable IME

    Proprietary Names

    FLEXIKOLD STANDARD COLD PACK NATRACURE UNIVERSAL WRAP W/BEADS THERMOACTIVE LARGE ANKLE NATRACURE ARCH HOT/COLD WRAP (350x90mm) PF COMPRESSION ARCH SLEEVE THERMOACTIVE LARGE KNEE DRY EYE MOISTURE H/C MASK COLD SLEEVE NATRACURE HEAT THERAPY BOOTIES FLEXIKOLD NECK COLD PACK THERMOACTIVE KNEE 4" CIRCLE GEL COLD PACK NATRACURE COLD THERAPY SOCKS NATRACURE UNIVERSAL COLD PACK ICE WRAP COMPRESSION HEEL SLEEVE NATRACURE HOT/COLD 5-MINUTE ARCH FIXER THERMOACTIVE WRIST FLEXIKOLD HALF SIZE COLD PACK THERMOACTIVE ELBOW GEL PACK DRY EYE MOISTURE H/C MASK - SILICA BEADS THERMOACTIVE ELBOW NATRACURE HOT/COLD FOOT & ARCH RELIEF (BLUE) COMPRESSION FOOT SLEEVES NATRACURE HEAT THERAPY MITTENS THERMOACTIVE THIGH GEL PACK MAGNETIC SHOULDER SUPPORT NATRACURE WARMING SHOULDER & BODY WRAP THERMOACTIVE LARGE ANKLE GEL PACK COMPRESSION KNEE SLEEVE THERMOACTIVE ANKLE THERMOACTIVE SHOULDER GEL PACK LEFT/RIGHT FLEXIKOLD OVERSIZE COLD PACK THERMOACTIVE KNEE GELPACK THERMOACTIVE BACK THERMOACTIVE ARM/CALF GEL PACK NATRACURE COLD THERAPY BOOTIES SB EXTREME MOISTURE SHOULDER THERMOACTIVE LARGE KNEE GELPACK NATRACURE SHOULDER & BODY WRAP W/BEADS 4" Circle Cold Pack - 2 PK THERMOACTIVE BACK GEL PACK THERMOACTIVE ANKLE GEL PACK THERMOACTIVE THIGH THERMOACTIVE ARM/CALF NATRACURE HOT/COLD FASCIA RELIEF SOCK THERMOACTIVE WRIST GEL PACK NATRACURE NECK WRAP W/BEADS NATRACURE HOT/COLD FOOT & ARCH RELIEF (BLACK) THEROMACTIVE SHOULDER LEFT/RIGHT CHEMO COLD MITTS CHEMO COLD CAP CHEMO COLD SLIPPERS

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility