BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Integra® Miltex®

    DI: 10381780171928 · Model: 33513 · INTEGRA LIFESCIENCES PRODUCTION CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Integra® Miltex®
    Primary DI
    10381780171928
    Version / Model
    33513
    Company Name
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION
    Labeler DUNS
    081277700
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-16
    Public Version
    6
    Public Version Date
    2022-07-13
    Public Version Status
    Update
    Public Device Record Key
    d1f7f719-50d4-49df-9eeb-385603a297cd
    Distribution End Date
    2022-05-01

    Device Description

    CryoSolutions Dermatology Tip

    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
    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
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    GEH UNIT, CRYOSURGICAL, ACCESSORIES

    GMDN Terms

    Code Name
    11067 General cryosurgical system, cryogen gas, mechanical

    Identifiers

    Type ID
    Secondary H834335131
    Primary 10381780171928

    Customer Contacts

    Phone
    +1(800)654-2873
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K091721 000