BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Auto Suture

    DI: 10884521066397 · Model: 1011 · Covidien LP
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Auto Suture
    Primary DI
    10884521066397
    Version / Model
    1011
    Company Name
    Covidien LP
    Labeler DUNS
    058614483
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    6
    Public Version Date
    2023-01-20
    Public Version Status
    Update
    Public Device Record Key
    9ada27d4-4f4a-42ea-9d7d-59beef8ea189
    Distribution End Date
    2020-11-03

    Device Description

    Anti-Fog Kit

    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
    FEB ACCESSORIES, CLEANING, FOR ENDOSCOPE

    GMDN Terms

    Code Name
    45225 Endoscope antifog solution

    Identifiers

    Type ID
    Package 20884521066394
    Primary 10884521066397

    Customer Contacts

    Phone
    +1(508)261-8000
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K944249 000

    Storage Conditions

    Type
    Handling Environment Temperature
    Temperature Range
    – 130 Degrees Fahrenheit