BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    8F Base Camp Sheath System

    DI: 00853799007404 · Model: FD 0743 · ROUTE 92 MEDICAL
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    8F Base Camp Sheath System
    Primary DI
    00853799007404
    Version / Model
    FD 0743
    Catalog Number
    REF 5001
    Company Name
    ROUTE 92 MEDICAL
    Labeler DUNS
    067429673
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-09-17
    Public Version
    3
    Public Version Date
    2021-12-22
    Public Version Status
    Update
    Public Device Record Key
    81097905-dffc-4424-8e9f-2f01d7c37dd6

    Device Description

    8F Base Camp Sheath System

    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
    DQY Catheter, Percutaneous

    GMDN Terms

    Code Name
    17846 Vascular guide-catheter, single-use

    Identifiers

    Type ID
    Primary 00853799007404