BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BIORAPTOR/ULTRABRAID

    DI: 03596010585950 · Model: 72200774 · Smith & Nephew, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BIORAPTOR/ULTRABRAID
    Primary DI
    03596010585950
    Version / Model
    72200774
    Catalog Number
    72200774
    Company Name
    Smith & Nephew, Inc.
    Labeler DUNS
    045483575
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-01-10
    Public Version
    6
    Public Version Date
    2023-09-07
    Public Version Status
    Update
    Public Device Record Key
    897a4048-53c5-47e0-93ae-9bc34c4b13c4

    Device Description

    BIORAPTOR 2.9 WITH 1 ULTRABRAID

    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
    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
    No

    Product Codes

    Code Name
    HWC Screw, fixation, bone

    GMDN Terms

    Code Name
    45061 Tendon/ligament bone anchor, bioabsorbable

    Identifiers

    Type ID
    Primary 03596010585950

    Customer Contacts

    Phone
    +1(800)238-7538
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K151105 000

    Storage Conditions

    Type
    Handling Environment Temperature
    Temperature Range
    0 – 140 Degrees Fahrenheit
    Type
    Handling Environment Temperature
    Temperature Range
    0 – 60 Degrees Celsius