BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    PROLITE ULTRA

    DI: 00650862308013 · Model: 30801 · Atrium Medical Corporation
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PROLITE ULTRA
    Primary DI
    00650862308013
    Version / Model
    30801
    Company Name
    Atrium Medical Corporation
    Labeler DUNS
    051798999
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2015-09-24
    Public Version
    8
    Public Version Date
    2022-06-10
    Public Version Status
    Update
    Public Device Record Key
    10ee0ffc-d306-4293-a2ad-4f0b6586f981
    Distribution End Date
    2019-12-31

    Device Description

    ProLite Ultra, SFP MEDIUM W/ONLAY, 1.25in. x 2in. (3.2cm x 5cm), 4in. (10cm)

    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
    MR Safe
    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
    FTL Mesh, surgical, polymeric

    GMDN Terms

    Code Name
    60300 Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable

    Identifiers

    Type ID
    Package 20650862308017
    Primary 00650862308013

    Premarket Submissions

    Submission Number Supplement Number
    K002093 000
    K151437 000