BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Speedlock

    DI: 00848657055451 · Model: 8514-85-R/8511-00 · NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Speedlock
    Primary DI
    00848657055451
    Version / Model
    8514-85-R/8511-00
    Company Name
    NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
    Labeler DUNS
    839138955
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-12-13
    Public Version
    3
    Public Version Date
    2019-08-21
    Public Version Status
    Update
    Public Device Record Key
    82f2edab-ab28-47e3-bef9-d692dbefe632

    Device Description

    DeBakey, 5mm, Atraumatic Serrations with Ratchet Handle: 8511-00 Composite Flip Lock, 34cm Length

    Device Characteristics

    Single Use
    No
    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
    No
    Has Serial Number
    Yes
    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
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    GEI ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

    GMDN Terms

    Code Name
    35080 Rigid endoscopic tissue manipulation forceps, reusable

    Identifiers

    Type ID
    Primary 00848657055451