BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Aspen® Flexible Light Handle Adapter

    DI: 00840113205189 · Model: LT-9631 · ASPEN SURGICAL PRODUCTS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Aspen® Flexible Light Handle Adapter
    Primary DI
    00840113205189
    Version / Model
    LT-9631
    Company Name
    ASPEN SURGICAL PRODUCTS, INC.
    Labeler DUNS
    027680821
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-02-25
    Public Version
    2
    Public Version Date
    2022-04-06
    Public Version Status
    Update
    Public Device Record Key
    0a03896a-20da-4017-8eec-7c692f51c6cc

    Device Description

    Single used Intent to be used as a sterile interface between the non-sterile Surgical Light and Surgeon or Nurse.

    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
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    FTA Light, surgical, accessories

    GMDN Terms

    Code Name
    37089 Light source adaptor

    Identifiers

    Type ID
    Package 00840113205196
    Primary 00840113205189

    Customer Contacts

    Phone
    +1(616)698-7100
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K020304 000