BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Scanlan® SUTURE BOOT™ Instrument Jaw Covers

    DI: 00846159028430 · Model: 1001-516BX · SCANLAN INTERNATIONAL INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Scanlan® SUTURE BOOT™ Instrument Jaw Covers
    Primary DI
    00846159028430
    Version / Model
    1001-516BX
    Catalog Number
    1001-516BX
    Company Name
    SCANLAN INTERNATIONAL INC
    Labeler DUNS
    023055619
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-07-28
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    317aac62-274f-4fa1-8205-630b437b512d

    Device Description

    Scanlan® SUTURE BOOT™ Instrument Jaw Covers - Large Pink, standard pkg, BNS (1000 per bag)

    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
    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Radiation Sterilization

    Product Codes

    Code Name
    KDC Instrument, Surgical, Disposable

    GMDN Terms

    Code Name
    35257 Vascular booties

    Identifiers

    Type ID
    Primary 00846159028430

    Customer Contacts

    Phone
    651-298-0997
    Email
    [email protected]