BEUDAMED
    FDA Registration Active 🇺🇸 United States

    (OEM) OASIS LOW TEMP CAUTERY

    Reg #: 1319639 · FEI: 1000138054 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    16
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics U.S., LLC
    Registration Number
    1319639
    FEI Number
    1000138054
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    84 Park Rd
    City
    Queensbury
    State
    NY
    ZIP
    12804
    Country
    US

    Regulatory Submissions

    510(k) Number
    K771189

    Owner / Operator

    Firm Name
    Sotera Health LLC
    Operator Number
    10029425
    Address
    2015 Spring Road, Suite 650
    City
    Oak Brook
    State
    IL
    Postal Code
    60523
    Country
    US
    Correspondent
    Karen Whaley-Krumins

    Products

    Device Name Product Code
    Unit, Cautery, Thermal, Battery-Powered HQP

    Proprietary Names

    (OEM) OASIS LOW TEMP CAUTERY k771189 ACCU-TEMP HIGH TEMPERATURE CAUTERY 2 IN SHAFT WITH FINE TIP MEDLINE HIGH TEMP CAUTERY, LOOP MEDLINE LOW TEMP CAUTERY, FINE ACCU-TEMP VARIABLE HIGH TEMPERATURE CAUTERY 1/2 IN SHAFT WITH FINE TIP ACCU-TEMP INTERCHANGEABLE CAUTERY TIP SINGLE USE LOOP TIP ACCU-TEMP HIGH TEMPERATURE CAUTERY 1/2 IN SHAFT WITH LOOP TIP MEDLINE HIGH TEMP CAUTERY, ELONGATED ACCU-TEMP INTERCHANGEABLE CAUTERY TIP SINGLE USE FINE TIP ACCU-TEMP VARIABLE LOW TEMPERATURE CAUTERY 1/2 IN SHAFT WITH FINE TIP MEDLINE HIGH TEMP CAUTERY, FINE ACCU-TEMP HIGH TEMPERATURE CAUTERY 1/2 IN SHAFT WITH FINE TIP ACCU-TEMP HIGH TEMPERATURE CAUTERY VASECTOR ELONGATED FINE TIP ACCU-TEMP LOW TEMPERATURE CAUTERY 1/2 IN SHAFT WITH FINE TIP ACCU-TEMP HIGH TEMPERATURE CAUTERY 2 IN SHAFT WITH LOOP TIP

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)