BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GBX Fixer and Replenisher

    Reg #: 3029911 · FEI: 1000524463 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    15
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Carestream Health, Inc.
    Registration Number
    3029911
    FEI Number
    1000524463
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    8124 Pacific Ave
    City
    WHITE CITY
    State
    OR
    ZIP
    97503
    Country
    US

    Owner / Operator

    Firm Name
    Carestream Health, Inc.
    Operator Number
    9097221
    Address
    150 Verona Street
    City
    Rochester
    State
    NY
    Postal Code
    14608
    Country
    US
    Correspondent
    Alyssa J Haig

    Products

    Device Name Product Code
    Film, Radiographic IWZ

    Proprietary Names

    GBX Fixer and Replenisher INSIGHT T-MAT G/RA T-MAT G/RA Film DRYVIEW DVM+ Mammography Laser Imaging Film Ultra-speed DRYVIEW DVB+ Laser Imaging Film X-OMAT 2 Dental Duplicating DRYVIEW DVB+ Premium Laser Imaging Film DRYVIEW DVE Laser Imaging Film AERMEI AMV Laser Imaging Film 125SH 35X43CM (14X17IN) AMV AERMEI AMV Laser Imaging Film 125SH 25X30CM (10X12IN) AMV GBX Developer and Replenisher AERMEI AMV Laser Imaging Film 125SH 28X35CM (11X14IN) AMV AERMEI AMV Laser Imaging Film 125SH 20X25CM (8X10IN) AMV

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device