BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CrOC

    DI: M68931200050 · Model: 05 · Safeguard US Operating, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CrOC
    Primary DI
    M68931200050
    Version / Model
    05
    Catalog Number
    31-200
    Company Name
    Safeguard US Operating, LLC
    Labeler DUNS
    118492643
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-01-27
    Public Version
    3
    Public Version Date
    2022-04-12
    Public Version Status
    Update
    Public Device Record Key
    b78bd7fc-6d0c-48d6-b921-0df08710a68c

    Device Description

    The CRoC is indicated for use in the battlefield to control difficult bleeds in the inguinal and axilla areas. The CRoC is also indicated for use in the battlefield as a last resort for life threatening bleeds of the carotid artery. The CRoC should be applied by a trained medical provider.

    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DXC Clamp, Vascular

    GMDN Terms

    Code Name
    43387 Clamp jaw cover, non-sterile

    Identifiers

    Type ID
    Primary M68931200050