BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Rotation Medical Reconstituted Collagen Scaffold - Arthroscopic, Hybrid

    DI: 00854501006098 · Model: 2169-4 · Smith & Nephew, Inc.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Rotation Medical Reconstituted Collagen Scaffold - Arthroscopic, Hybrid
    Primary DI
    00854501006098
    Version / Model
    2169-4
    Company Name
    Smith & Nephew, Inc.
    Labeler DUNS
    045483575
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-11-28
    Public Version
    7
    Public Version Date
    2023-10-04
    Public Version Status
    Update
    Public Device Record Key
    0200a470-eef2-43d5-8641-962c255a7e0e
    Distribution End Date
    2022-06-16

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    OWY Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
    ORQ Mesh, Surgical, Deployer

    GMDN Terms

    Code Name
    60907 Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial

    Identifiers

    Type ID
    Primary 00854501006098