BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Blue Sky Bio, LLC.

    DI: 00815131024128 · Model: AMUSIH3530 · BLUE SKY BIO LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Blue Sky Bio, LLC.
    Primary DI
    00815131024128
    Version / Model
    AMUSIH3530
    Company Name
    BLUE SKY BIO LLC
    Labeler DUNS
    618960848
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-19
    Public Version
    6
    Public Version Date
    2019-11-08
    Public Version Status
    Update
    Public Device Record Key
    adfc4a50-f8b0-4426-ab09-b3177b5de0b6

    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NHA Abutment, Implant, Dental, Endosseous

    GMDN Terms

    Code Name
    44879 Dental implant suprastructure, permanent, preformed

    Identifiers

    Type ID
    Primary 00815131024128

    Premarket Submissions

    Submission Number Supplement Number
    K060957 000
    K112875 000