BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    gastroduodenal FTRD Set

    DI: 04260206310655 · Model: FTRD 13 · Ovesco Endoscopy AG
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    gastroduodenal FTRD Set
    Primary DI
    04260206310655
    Version / Model
    FTRD 13
    Catalog Number
    200.72
    Company Name
    Ovesco Endoscopy AG
    Labeler DUNS
    344007369
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-06-05
    Public Version
    1
    Public Version Date
    2020-06-15
    Public Version Status
    New
    Public Device Record Key
    6d4fbbbd-6850-47b7-910f-77ef01d635de

    Device Description

    The gastroduodenal FTRD Set is a novel tool for diagnostic and therapeutic full-thickness (or deep wall resection, especially in the stomach) resection via flexible endoscopy in the stomach and duodenum • technology is based on the well-established OTSC System • enabling the endoscopist to resect all layers of suitable lesions including the serosa • the transection of the tissue happens only after the tissue has been closed completely • bowel lumen and abdominal cavity won't get into contact • It consists of the following five instruments, all single-use: • gastroduodenal FTRD (application cap with preloaded clip (special design for use in duodenum), integrated HF snare, endoscope sleeve, hand wheel and thread retriever • for colonoscopes) • FTRD Marking Probe (HF coagulation probe | marking of the target lesion in preparation of FTRD use | for detection and complete resection of the right tissue) • FTRD Grasper (specially designed grasping forceps | proper grip on the target tissue | precise retrieval of the sample into the application cap of the FTRD) • Insertion balloon (used to facilitate the insertion of the gastroduodenal FTRD through the mouth in the upper GI tract | consists of a balloon, radiopaque markers, a catheter, a three-way handle and a yellow marker) • Guide wire (provided as insertion aid for the gastroduodenal FTRD to facilitate the insertion of the device into the upper GI-tract | used in conjunction with an insertion balloon)

    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
    Yes
    MRI Safety
    MR Conditional
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    PKL Hemostatic Metal Clip For The Gi Tract
    FDI Snare, Flexible
    KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

    GMDN Terms

    Code Name
    61455 Endoscopic electrosurgical full-thickness tissue biopsy/resection set

    Identifiers

    Type ID
    Primary 04260206310655

    Customer Contacts

    Phone
    +19196519449
    Email
    [email protected]
    Phone
    +49707196528160
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K200684 000

    Device Sizes

    Type Value Unit Text
    Balloon Length 1800 Millimeter
    Balloon Diameter 20 Millimeter
    Guidewire Length 3700 Millimeter
    Guidewire Diameter 0.035 Inch
    Device Size Text, specify for endoscopes with diameter of 10.5 - 12.0 mm
    Device Size Text, specify working length 220 cm
    Device Size Text, specify working channel diameter 2.8 mm

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    10 – 35 Degrees Celsius
    Type
    Storage Environment Humidity
    Temperature Range
    15 – 70 Percent (%) Relative Humidity