BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Blue Sky Bio, LLC.

    DI: 00810060227053 · Model: 5.1 · BLUE SKY BIO LLC
    View on AccessGUDID
    Product Codes
    6
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Blue Sky Bio, LLC.
    Primary DI
    00810060227053
    Version / Model
    5.1
    Catalog Number
    BSP
    Company Name
    BLUE SKY BIO LLC
    Labeler DUNS
    618960848
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-04-13
    Public Version
    1
    Public Version Date
    2026-04-21
    Public Version Status
    New
    Public Device Record Key
    e21f43dd-9053-4b3c-948c-579fdb31f3c5

    Device Description

    Blue Sky Plan Software (Surgical Guide)

    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
    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
    NXC Aligner, Sequential
    PZY Additively Manufactured, Preformed, Resin Denture Tooth
    DYW Bracket, Plastic, Orthodontic
    NOF System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
    PNN Orthodontic Software
    LLZ System, Image Processing, Radiological

    GMDN Terms

    Code Name
    60883 Dental treatment application software

    Identifiers

    Type ID
    Primary 00810060227053