BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Memory Staple

    DI: B56217631WB0 · Model: 17631WB · Wishbone Medical, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Memory Staple
    Primary DI
    B56217631WB0
    Version / Model
    17631WB
    Company Name
    Wishbone Medical, Inc.
    Labeler DUNS
    062355158
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-08-06
    Public Version
    4
    Public Version Date
    2023-04-03
    Public Version Status
    Update
    Public Device Record Key
    621e0041-ae2e-4dae-aa48-a3394e22acf2
    Distribution End Date
    2023-03-16

    Device Description

    Memory Staple 11 x 10-1.5 x 1.5mm / SM

    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
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JDR Staple, Fixation, Bone

    GMDN Terms

    Code Name
    61669 Orthopaedic bone staple, non-adjustable

    Identifiers

    Type ID
    Primary B56217631WB0

    Premarket Submissions

    Submission Number Supplement Number
    K061798 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    – 24 Degrees Celsius
    Type
    Storage Environment Temperature
    Temperature Range
    – 75 Degrees Fahrenheit