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    FDA Registration Active 🇺🇸 United States

    StrykerSustainability (SP) - Flowtron DVT Calf Garment Calf

    Reg #: 1047843 · FEI: 1047843 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    45
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ISOMEDIX OPERATIONS INC.
    Registration Number
    1047843
    FEI Number
    1047843
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2072 SOUTHPORT RD., HWY. 295
    City
    SPARTANBURG
    State
    SC
    ZIP
    29306
    Country
    US

    Regulatory Submissions

    510(k) Number
    K100909

    Owner / Operator

    Firm Name
    STERIS Corporation
    Operator Number
    1527821
    Address
    5960 Heisley Rd, --
    City
    Mentor
    State
    OH
    Postal Code
    44060
    Country
    US

    Products

    Device Name Product Code
    Sleeve, Limb, Compressible JOW

    Proprietary Names

    StrykerSustainability (SP) - Flowtron DVT Calf Garment Calf StrykerSustainability (SP) - Calf Sleeve - Pair Large up to 25 1/2" StrykerSustainability (SP) - Thigh Sleeve Large StrykerSustainability (SP) - Thigh Garment - One Pair Large StrykerSustainability (SP) - VenaFlow Thigh Garment with Pos Lock Up to 29" StrykerSustainability (SP) - Vaso Press Foot Garment Large StrykerSustainability (SP) - Vaso Press Calf Compression Sleeve Medium up to 18" StrykerSustainability (SP) - Calf Sleeve Short StrykerSustainability (SP) - Foot Sleeve up to 14.5" StrykerSustainability (SP)- Foot Garment - One Pair Large StrykerSustainability (SP) - VenaFlow Disposable Foot Cuff StrykerSustainability (SP) - Foot Garment Universal Large StrykerSustainability (SP) - Vaso Press Foot Garment Foot Size up to US13 StrykerSustainability (SP) - SCD Express Compression Sleeve Foot Cuff Regular StrykerSustainability (SP) - Alternating Leg Pressure Pair Calf Large StrykerSustainability (SP) - Impad Rigid Sole Foot Cover Right and Left Foot Regular StrykerSustainability (SP) - Alternating Leg Pressure Pair Foot Regular Up to 12 EEE StrykerSustainability (SP) - Alternating Leg Pressure Pair Calf Regular StrykerSustainability (SP) - VenaFlow Disposable Thigh Cuff StrykerSustainability (SP) - Vaso Press Calf Compression Sleeve Large up to 24" StrykerSustainability (SP) - Alternating Leg Pressure Pair Thigh Regular StrykerSustainability (SP) - Thigh Sleeve Small StrykerSustainability (SP) - Impad Rigid Sole Foot Cover Right and Left Foot Large StrykerSustainability (SP) - Vaso Press Calf Garment Large Up to 24" StrykerSustainability (SP) - VenaFlow Calf Garment with Pos Lock Up to 19" StrykerSustainability (SP) - Vaso Press Thigh Garment DVT Prophylaxis System Large / up to 36" StrykerSustainability (SP) - VenaFlow Disp XL Calf Cuff StrykerSustainability (SP) - Calf Garment - One Pair Extra Large StrykerSustainability (SP) - VenaFlow Disposable Calf Cuff StrykerSustainability (SP) - Calf Sleeve - Pair Fits up to 21 1/2 in Medium StrykerSustainability (SP) - Flowtron Thigh Garment Thigh StrykerSustainability (SP) - Foot Garment - One Pair Regular StrykerSustainability (SP) - Calf Garment - One Pair Large StrykerSustainability (SP) - Calf Sleeve Medium StrykerSustainability (SP) - Vaso Press Thigh Compression Sleeve Medium up to 29" StrykerSustainability (SP) - Vaso Press Calf Garment Medium Up to 18" StrykerSustainability (SP) - Calf Sleeve Large StrykerSustainability (SP) - Calf Garment - One Pair Regular StrykerSustainability (SP) - Vaso Press Thigh Garment DVT Prophylaxis System Medium / up to 29" StrykerSustainability (SP) - SCD Express Compression Sleeve Foot Cuff Large StrykerSustainability (SP) - VenaFlow XL Calf Garment with Pos Lock Up to 22" StrykerSustainability (SP) - VenaFlow Foot Garment with Pos Lock Up to 16" StrykerSustainability (SP) - Thigh Sleeve Medium StrykerSustainability (SP) - Thigh Garment - One Pair Regular StrykerSustainability (SP) - Vaso Press Thigh Compression Sleeve Large up to 36"

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)