BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Puregraft Instrument Set

    DI: 00850034511030 · Model: 550/IS SST · Bimini Technologies LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Puregraft Instrument Set
    Primary DI
    00850034511030
    Version / Model
    550/IS SST
    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
    639467a4-6b0f-41e1-8680-4be75a9e4435

    Device Description

    Is composed of the Puregraft Easel and Puregraft Slider. Both components are made of autoclavable stainless steel. The Easel holds the Puregraft Bag in place, and the Slider tool is used on the exterior of the Puregraft Bag to compress and facilitate the movement of liquids through the filter mesh and into the Drain Bag.

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    MDM Instrument, Manual, Surgical, General Use

    GMDN Terms

    Code Name
    13959 Instrument table

    Identifiers

    Type ID
    Primary 00850034511030