BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Micro Seal Augmented 20 Degree Liner

    DI: B046WB111380 · Model: 32x62x20 · SIGNAL MEDICAL CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Micro Seal Augmented 20 Degree Liner
    Primary DI
    B046WB111380
    Version / Model
    32x62x20
    Catalog Number
    WB-1-1138
    Company Name
    SIGNAL MEDICAL CORPORATION
    Labeler DUNS
    169289308
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-02-12
    Public Version
    4
    Public Version Date
    2020-09-09
    Public Version Status
    Update
    Public Device Record Key
    149ae270-3eeb-4a41-b840-7fd576b0c152

    Device Description

    Micro Seal Augmented 20 Degree Liner 32x62x20

    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
    Yes
    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
    LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

    GMDN Terms

    Code Name
    33695 Bipolar femoral head outer component, hemiarthroplasty

    Identifiers

    Type ID
    Primary B046WB111380

    Customer Contacts

    Phone
    810-364-7070
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K955271 000