BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Fisherbrand

    DI: 00613647000007 · Model: SCLF1015 · FISHER SCIENTIFIC COMPANY L.L.C.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    100

    Basic Information

    Brand Name
    Fisherbrand
    Primary DI
    00613647000007
    Version / Model
    SCLF1015
    Catalog Number
    0181257
    Company Name
    FISHER SCIENTIFIC COMPANY L.L.C.
    Labeler DUNS
    004321519
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    100
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    4
    Public Version Date
    2022-11-14
    Public Version Status
    Update
    Public Device Record Key
    b79b23c5-fa3b-4939-8f65-0b2ee2283985

    Device Description

    10X15INSLF SEL ATCLV PCH 100PK

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KCT Sterilization wrap containers, trays, cassettes & other accessories

    GMDN Terms

    Code Name
    13735 Sterilization packaging, single-use

    Identifiers

    Type ID
    Package 20613647000001
    Primary 00613647000007
    Unit of Use 10613647000004

    Customer Contacts

    Phone
    +018007667000
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K941327 000