BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    GAP ENDO-EXO MEDULLARY SYSTEM

    DI: 07540194009944 · Model: GAP-ILE120 · Pega Medical Inc
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    GAP ENDO-EXO MEDULLARY SYSTEM
    Primary DI
    07540194009944
    Version / Model
    GAP-ILE120
    Catalog Number
    GAP-ILE120
    Company Name
    Pega Medical Inc
    Labeler DUNS
    257315713
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-08-12
    Public Version
    5
    Public Version Date
    2022-09-16
    Public Version Status
    Update
    Public Device Record Key
    c4e7d4a0-aeee-4d83-ab28-79abfa75335b

    Device Description

    EMPTY GAP LAG INSTRUMENTS CASE

    Device Characteristics

    Single Use
    No
    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
    Yes
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    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
    LXH ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    GMDN Terms

    Code Name
    12143 Instrument tray, reusable

    Identifiers

    Type ID
    Primary 07540194009944

    Customer Contacts

    Phone
    +1(450)688-5144 ext. 242
    Email
    [email protected]

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    keep at room temperature