BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Composite™ ePTFE-Coated Extended Anatomical Chin

    DI: M724EPTFEEACL1 · Model: Size: Large · IMPLANTECH ASSOCIATES, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Composite™ ePTFE-Coated Extended Anatomical Chin
    Primary DI
    M724EPTFEEACL1
    Version / Model
    Size: Large
    Catalog Number
    ePTFE-EAC-L
    Company Name
    IMPLANTECH ASSOCIATES, INC.
    Labeler DUNS
    784664955
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2015-09-24
    Public Version
    4
    Public Version Date
    2019-11-14
    Public Version Status
    Update
    Public Device Record Key
    5601bdbe-9aed-4919-9336-88daa30d7d4d

    Device Description

    Chin Implant

    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LZK Implant, Malar

    GMDN Terms

    Code Name
    35261 Chin prosthesis

    Identifiers

    Type ID
    Primary M724EPTFEEACL1

    Customer Contacts

    Phone
    1-800-733-0833
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K002886 000