BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    C2 CryoBalloon EndoGrip

    DI: 00854924006408 · Model: FG-1040 · PENTAX OF AMERICA, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    C2 CryoBalloon EndoGrip
    Primary DI
    00854924006408
    Version / Model
    FG-1040
    Company Name
    PENTAX OF AMERICA, INC.
    Labeler DUNS
    083211284
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-07-29
    Public Version
    2
    Public Version Date
    2021-04-07
    Public Version Status
    Update
    Public Device Record Key
    d8638dfc-11f6-4475-b831-af09861fbe2e

    Device Description

    EndoGrip

    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
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OCX Endoscopic Irrigation/Suction System

    GMDN Terms

    Code Name
    11067 General cryosurgical system, cryogen gas, mechanical

    Identifiers

    Type ID
    Primary 00854924006408

    Premarket Submissions

    Submission Number Supplement Number
    K193036 000