BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    EB/RA Film

    DI: 40889978009516 · Model: EB/RA Film · CARESTREAM HEALTH, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    100

    Basic Information

    Brand Name
    EB/RA Film
    Primary DI
    40889978009516
    Version / Model
    EB/RA Film
    Catalog Number
    8009516
    Company Name
    CARESTREAM HEALTH, INC.
    Labeler DUNS
    793169512
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    100
    Record Status
    Published
    Publish Date
    2016-09-16
    Public Version
    3
    Public Version Date
    2018-07-30
    Public Version Status
    Update
    Public Device Record Key
    d3bae5d4-a7b9-4f86-86bc-7931ecc22617
    Distribution End Date
    2018-07-26

    Device Description

    100SH 11X14 EB/RA 4153

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    IWZ Film, radiographic

    GMDN Terms

    Code Name
    40980 Medical x-ray film, non-screen

    Identifiers

    Type ID
    Package 60889978009510
    Primary 40889978009516
    Unit of Use 00889978009518