BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    LATERA

    DI: 00857037006044 · Model: LATANI02 · ENTELLUS MEDICAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    2

    Basic Information

    Brand Name
    LATERA
    Primary DI
    00857037006044
    Version / Model
    LATANI02
    Company Name
    ENTELLUS MEDICAL, INC.
    Labeler DUNS
    017283879
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    2
    Record Status
    Published
    Publish Date
    2016-07-21
    Public Version
    6
    Public Version Date
    2023-07-07
    Public Version Status
    Update
    Public Device Record Key
    5ffa80ff-9d39-405d-a8d8-1bf96e199c05
    Distribution End Date
    2020-09-18

    Device Description

    Absorbable Nasal 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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NHB Polymer, Ear, Nose And Throat, Synthetic, Absorbable

    GMDN Terms

    Code Name
    62157 Nasal implant, synthetic polymer, bioabsorbable

    Identifiers

    Type ID
    Primary 00857037006044
    Unit of Use 00857037006068
    Package 00857037006969

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    – 30 Degrees Celsius