BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PuraGel 3mL

    DI: 00860007400308 · Model: 651-005 · 3-D MATRIX INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PuraGel 3mL
    Primary DI
    00860007400308
    Version / Model
    651-005
    Catalog Number
    651-005
    Company Name
    3-D MATRIX INC.
    Labeler DUNS
    058207695
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-09-20
    Public Version
    1
    Public Version Date
    2023-09-28
    Public Version Status
    New
    Public Device Record Key
    02e11a37-9c06-4894-ae16-eb2f7d717d53

    Device Description

    PuraGel is a hemostat for mild and moderate bleeding intended to be used in a variety of indications. (3 ml)

    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
    NHB Polymer, Ear, Nose And Throat, Synthetic, Absorbable

    GMDN Terms

    Code Name
    60919 Synthetic peptide haemostatic agent

    Identifiers

    Type ID
    Primary 00860007400308

    Premarket Submissions

    Submission Number Supplement Number
    K183015 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius