BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Bayer1673 (SX) - Stellant Dual Syringe Quad-Pak with Spikes

    Reg #: 3009882464 · FEI: 3009882464 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    14
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Synergy Health AST, LLC
    Registration Number
    3009882464
    FEI Number
    3009882464
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    7225 N Noah Dr
    City
    Saxonburg
    State
    PA
    ZIP
    16056
    Country
    US

    Regulatory Submissions

    510(k) Number
    K023183

    Owner / Operator

    Firm Name
    Synergy Health AST, LLC
    Operator Number
    10028672
    Address
    5960 Heisley Road
    City
    Mentor
    State
    OH
    Postal Code
    44060
    Country
    US

    Products

    Device Name Product Code
    Injector And Syringe, Angiographic DXT

    Proprietary Names

    Bayer1673 (SX) - Stellant Dual Syringe Quad-Pak with Spikes Bayer1673 (SX) - Stellant Dual Syringe Quad-Pak with a Large Saline Spike and a Small Contrast Spike Bayer1673 (SX) - Stellant Single Syringe Tri-Pak Kit with QFT Bayer1673 (SX) - Stellant Single Syringe Kit with QFT Bayer1673 (SX) - Stellant Single Syringe Kit with SPK Bayer1673 (SX) - Stellant Single Syringe Tri-Pak Kit with SPK Bayer1673 (SX) - Stellant Dual Quad-Pak with QFT Bayer1673 (SX) - Single Syringe Tri-Pak with Spike Bayer1673 (SX) - Dual Syringe Quad-Pak with Spikes Bayer1673 (SX) - Dual Syringe Quad-Pak with a Large Saline Spike and a Small Contrast Spike Bayer1673 (SX) - Single Syringe with Spike Bayer1673 (SX) - Single Syringe Tri-Pak with QFT Bayer1673 (SX) - Dual Syringe Quad-Pak with QFT Bayer1673 (SX) - Single Syringe with QFT

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)