BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Spectrum, Inc.

    DI: 00850301007808 · Model: 987-03896-000 · SPECTRUM, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Spectrum, Inc.
    Primary DI
    00850301007808
    Version / Model
    987-03896-000
    Catalog Number
    725200
    Company Name
    SPECTRUM, INC.
    Labeler DUNS
    080458964
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-07-21
    Public Version
    6
    Public Version Date
    2020-02-06
    Public Version Status
    Update
    Public Device Record Key
    e3a92b1d-3bf3-4efa-867f-6aaf7a04861d

    Device Description

    Specimine Container, 16 Oz, Sterile

    Device Characteristics

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

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Ethylene Oxide

    Product Codes

    Code Name
    LPZ Container, frozen donor tissue storage

    GMDN Terms

    Code Name
    12535 Medical equipment drape, single-use

    Identifiers

    Type ID
    Package 10850301007805
    Primary 00850301007808

    Customer Contacts

    Phone
    +1(214)492-0506 ext. 3
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K863872 000