BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    OR Specific

    DI: 00841027100089 · Model: 419-HD-NS · OR SPECIFIC, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    OR Specific
    Primary DI
    00841027100089
    Version / Model
    419-HD-NS
    Catalog Number
    419-HD-NS
    Company Name
    OR SPECIFIC, INC.
    Labeler DUNS
    802587928
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-22
    Public Version
    3
    Public Version Date
    2018-11-08
    Public Version Status
    Update
    Public Device Record Key
    35522365-fd10-4dc4-ad12-5fa6f9ffe923

    Device Description

    Drape, Heavy Duty, NonSterile. Fits 5' Big Case Back Table model

    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
    Yes
    Sterilization Methods
    Ethylene Oxide

    Product Codes

    Code Name
    PUI Drape, Surgical, Exempt

    GMDN Terms

    Code Name
    47782 Patient surgical drape, single-use, non-sterile

    Identifiers

    Type ID
    Primary 00841027100089
    Package 10841027100086

    Customer Contacts

    Phone
    800-937-7949
    Email
    [email protected]