BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Earlens ELF USB

    DI: 00850013007042 · Model: ELF001 · EARLENS CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Earlens ELF USB
    Primary DI
    00850013007042
    Version / Model
    ELF001
    Catalog Number
    ELF001
    Company Name
    EARLENS CORPORATION
    Labeler DUNS
    611658795
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    10
    Public Version Date
    2023-11-03
    Public Version Status
    Update
    Public Device Record Key
    7274bf17-318c-4ede-a0e5-52af050bf458
    Distribution End Date
    2022-12-16

    Device Description

    Earlens Fitting Software. Lot Number is for manufacturing packaging of software. Version is in Application Identifier (8012).

    Device Characteristics

    Single Use
    No
    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
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    PLK Tympanic Membrane Direct Contact Hearing Aid

    GMDN Terms

    Code Name
    60211 Audiometric/hearing device software

    Identifiers

    Type ID
    Primary 00850013007042