BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Spectrum, Inc.

    DI: 00850301007228 · Model: 982-03964-000 · 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
    00850301007228
    Version / Model
    982-03964-000
    Catalog Number
    781984
    Company Name
    SPECTRUM, INC.
    Labeler DUNS
    080458964
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-01-30
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    5c862289-21b8-459d-a559-4f4017af64bd

    Device Description

    Sterile Equipment Drape, Ultrasonic Probe, 7"X96"

    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
    KKX Drape, surgical

    GMDN Terms

    Code Name
    45021 Instrument/equipment drape, single-use, sterile

    Identifiers

    Type ID
    Package 00850301007235
    Primary 00850301007228

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K934630 000