BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Promax Surgical Cover

    DI: 00634916047882 · Model: 95869695 · STANDARD TEXTILE CO., INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    36

    Basic Information

    Brand Name
    Promax Surgical Cover
    Primary DI
    00634916047882
    Version / Model
    95869695
    Catalog Number
    95869695
    Company Name
    STANDARD TEXTILE CO., INC.
    Labeler DUNS
    006999858
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    36
    Record Status
    Published
    Publish Date
    2018-01-29
    Public Version
    4
    Public Version Date
    2023-07-06
    Public Version Status
    Update
    Public Device Record Key
    78e3585f-9151-4a38-b260-e06f2196fef7
    Distribution End Date
    2018-01-29

    Device Description

    VENTRIC COVER 33X61 - PROMAX/WRAPPEL (S/R 12275)

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    No
    Has Donation ID
    No

    Sterilization

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

    Product Codes

    Code Name
    KKX Drape, Surgical

    GMDN Terms

    Code Name
    47780 Patient surgical drape, reusable

    Identifiers

    Type ID
    Primary 00634916047882
    Unit of Use 10634916047882

    Customer Contacts

    Phone
    1-800-999-0400
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K980183 000