BEUDAMED
    FDA Registration Active 🇺🇸 United States

    RapidPort EZ Access Port Kit for use with the Lap-Band AP System Standard

    Reg #: 3013508647 · FEI: 3013508647 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    12
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    ReShape Lifesciences
    Registration Number
    3013508647
    FEI Number
    3013508647
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    7625 Golden Triangle Dr Ste G
    City
    Eden Prairie
    State
    MN
    ZIP
    55344
    Country
    US

    Regulatory Submissions

    PMA Number
    P000008

    Owner / Operator

    Firm Name
    ReShape Lifesciences
    Operator Number
    10038397
    Address
    7625 Golden Triangle Drive, Suite G
    City
    Eden Prairie
    State
    MN
    Postal Code
    55344
    Country
    US
    Correspondent
    Alyssa James

    Products

    Device Name Product Code
    Implant, Intragastric For Morbid Obesity LTI

    Proprietary Names

    RapidPort EZ Access Port Kit for use with the Lap-Band AP System Standard Lap-Band AP System Large with RapidPort EZ ReShape Lap-Band 2 FLEX & Access Port, Standard ReShape Lap-Band 2 FLEX, Standard ReShape Lap-Band 2 FLEX & Access Port, Large Lap-Band System Access Port Needle 20 G x 51 mm (2 in.) ReShape Lap-Band 2, FLEX Tubing Kit Lap-Band System Access Port Needle 20 G x 89 mm (3.5 in.) Lap-Band AP System Standard with RapidPort EZ RapidPort EZ Access Port Kit for use with the Lap-Band AP System Large RapidPort EZ Port Applier ReShape Lap-Band 2 FLEX, Large

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198