BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AutoPose Restore

    DI: 00850034511276 · Model: ABS-101035-1 · Bimini Technologies LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    AutoPose Restore
    Primary DI
    00850034511276
    Version / Model
    ABS-101035-1
    Company Name
    Bimini Technologies LLC
    Labeler DUNS
    076649467
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-02-09
    Public Version
    1
    Public Version Date
    2022-02-17
    Public Version Status
    New
    Public Device Record Key
    79b7cd0b-0750-4802-91b2-19733171202b

    Device Description

    A sterile, single use microsizing syringe system intended for the harvesting, concentrating, and transferring of autologous adipose tissue back to the same patient when the transfer of harvested adipose tissue is desired. It consists of a 50 mL vacuum-lock syringe with a built-in, 800 micron filter for screening the tissue particle size to allow for easier injection through small, 18-21G injectors.

    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MUU System, Suction, Lipoplasty

    GMDN Terms

    Code Name
    56627 Autologous adipose tissue collection/washing set

    Identifiers

    Type ID
    Primary 00850034511276