BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Paul Banditt

    DI: D955RETHEN31 · Model: RETHEN3 · Terlain Enterprises, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Paul Banditt
    Primary DI
    D955RETHEN31
    Version / Model
    RETHEN3
    Company Name
    Terlain Enterprises, Inc.
    Labeler DUNS
    177465051
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-12-11
    Public Version
    1
    Public Version Date
    2023-12-19
    Public Version Status
    New
    Public Device Record Key
    12367258-e515-4c68-9f09-1a4e6a971b07

    Device Description

    PAUL BANDITT HENAHAN 3 RETRACTOR, FLAT HANDLE (18.5cm long, 15mm head width)

    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    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
    EIG Retractor, All Types

    GMDN Terms

    Code Name
    13380 Hand-held dental retractor

    Identifiers

    Type ID
    Primary D955RETHEN31