BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Arthrex®

    DI: 10888867042671 · Model: AR-8021-100 · ARTHREX, INC.
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    100

    Basic Information

    Brand Name
    Arthrex®
    Primary DI
    10888867042671
    Version / Model
    AR-8021-100
    Catalog Number
    AR-8021-100
    Company Name
    ARTHREX, INC.
    Labeler DUNS
    131747628
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    100
    Record Status
    Published
    Publish Date
    2021-12-03
    Public Version
    1
    Public Version Date
    2021-12-13
    Public Version Status
    New
    Public Device Record Key
    bd4e6787-545d-440b-b6ea-30687724a294

    Device Description

    2.8MM FASTAK ECONOMY PACK (100)

    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 Conditional
    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
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    JDR Staple, fixation, bone
    MBI Fastener, fixation, nondegradable, soft tissue
    HWC Screw, fixation, bone

    GMDN Terms

    Code Name
    45062 Tendon/ligament bone anchor, non-bioabsorbable

    Identifiers

    Type ID
    Unit of Use 00888867042674
    Secondary M150AR80211000
    Primary 10888867042671

    Customer Contacts

    Phone
    +1(800)934-4404
    Email
    [email protected]