BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Kay Kare

    DI: 00818634020017 · Model: 10-30105 DS · Bosma Enterprises
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Kay Kare
    Primary DI
    00818634020017
    Version / Model
    10-30105 DS
    Catalog Number
    10-30105 DS
    Company Name
    Bosma Enterprises
    Labeler DUNS
    878070325
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-07-02
    Public Version
    2
    Public Version Date
    2024-02-26
    Public Version Status
    Update
    Public Device Record Key
    77c85bf0-1fe2-4581-9ec9-ce4cbe0d9231
    Distribution End Date
    2024-02-23

    Device Description

    Kay Kare Brace Kit; Each Kit Includes Disposable Multi Purpose Wrap, and 35x4.25 Flat SAM Splint.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NOC Splint, Extremity, Non-Inflatable, External, Non-Sterile

    GMDN Terms

    Code Name
    64881 First aid limb splint, mouldable, single-use

    Identifiers

    Type ID
    Primary 00818634020017

    Customer Contacts

    Phone
    800-362-5463
    Email
    [email protected]

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    Avoid excessive heat. Keep dry.