BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PEAK® Platelet Rich Plasma System

    DI: 00812337026215 · Model: 64002-01 · DSM BIOMEDICAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PEAK® Platelet Rich Plasma System
    Primary DI
    00812337026215
    Version / Model
    64002-01
    Catalog Number
    278010
    Company Name
    DSM BIOMEDICAL, INC.
    Labeler DUNS
    131107757
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-17
    Public Version
    5
    Public Version Date
    2023-06-19
    Public Version Status
    Update
    Public Device Record Key
    84924fad-f514-4e49-8c5a-53398afb5e15

    Device Description

    Centrifuge for preparation of platelet rich plasma

    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
    Yes
    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
    ORG Platelet And Plasma Separator For Bone Graft Handling

    GMDN Terms

    Code Name
    47154 Haematological concentrate system centrifuge

    Identifiers

    Type ID
    Direct Marking 00812337026239
    Primary 00812337026215