BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AE-2 - FTN BARB 1/16 Y PLASTIC

    Reg #: 3017604 · FEI: 3017604 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    51
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ASEPTICO, INC.
    Registration Number
    3017604
    FEI Number
    3017604
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    8333 216th St SE
    City
    WOODINVILLE
    State
    WA
    ZIP
    98072
    Country
    US

    Regulatory Submissions

    510(k) Number
    K142124

    Owner / Operator

    Firm Name
    ASEPTICO, INC.
    Operator Number
    3017604
    Address
    8333 216TH ST., S.E., --
    City
    Woodinville
    State
    WA
    Postal Code
    98072
    Country
    US

    Products

    Device Name Product Code
    Handpiece, Direct Drive, Ac-Powered EKX

    Proprietary Names

    AE-2 - FTN BARB 1/16 Y PLASTIC AEU-6000 - IMPLANT SURGERY UNIT AEU-1070PTP-70V - IMPLANT SURGERY SYSTEM TOUCH SCREEN 70NCM PTP W/AE-70V FOOTSWITCH AE-230L-40EXT - MOTOR/CABLE ASSY AE-230L-40EXT LED LIGHTED W/10 FT CABLE AEU-6000ADN-110 - IMPLANT SURGERY UNIT ADIN W/AE-70V FOOTSWITCH AEU-6000SDI-70V - IMPLANT SURGERY UNIT SPIRALTECH W/AE-70V FOOTSWITCH AE-230M-40EXT - MOTOR/CABLE ASSY AE-230M-40EXT W/10 FT CABLE AEU-1000 - IMPLANT SURGERY SYSTEM TOUCH SCREEN AHP-07 - CANNULA CLIP SET AE-230M-40 - MOTOR/CABLE ASSY AE-230M-40 AEU-6000ARM-70V -IMPLANT SURGERY UNIT ARGON MEDICAL W/AE-70V FOOTSWITCH AEU-6000SWM - IMPLANT SURGERY SYSTEM SWEDEN & MARTINA AHP-07T - TUBE EXTERNAL IRRIGATION 6.5" L 42ID X .120OD AEU-6000GCR-70V - IMPLANT SURGERY UNIT GENICORE W/AE-70V FOOTSWITCH AEU-6000SWM-110 - IMPLANT SURGERY SYSTEM SWEDEN & MARTINA (US) AE-230L-40 - MOTOR/CABLE ASSY AE-230 LED LIGHTED AEU-6000ADN - IMPLANT SURGERY UNIT ADIN W/AE-70V FOOTSWITCH EURO CORD AE-23-PUMP - TUBING SET PUMP SECTION AEU-1000-70V - IMPLANT SURGERY SYSTEM TOUCH SCREEN W/AE-70V FOOTSWITCH AEU-6000GLI-70V - IMPLANT SURGERY SYSTEM GLIDEWELL W/AE-70V FOOTSWITCH AE-70V2BSB - FOOTSWITCH VARIABLE IMPLANT V2 BLUE SKY BIO AEU-6000PTP-70V -IMPLANT SURGERY UNIT PALTOP W/AE-70V FOOTSWITCH AE-3 - FTN BARB 1/16 CONNECTOR PLTD AEU-6000-OCO - IMPLANT SURGERY UNIT OCO BIOMEDICAL AEU-6000GLI - IMPLANT SURGERY SYSTEM GLIDEWELL AHP-06 - HPCE BODY CLIP AE-70V2MG-10 - FOOTSWITCH VARIABLE IMPLANT V2 MEGAGEN W/10FT CABLE AE-24 - TUBING SET AEU-1000 BAG AEU-1000-OCO - IMPLANT SURGERY SYSTEM TOUCH SCREEN OCO AEU-6000-IVS-70V - IMPLANT SURGERY UNIT IMPLANT VISION W/AE-70V FOOTSWITCH AE-24-PUMP - TUBING SET PUMP SECTION AEU-1000 AEU-1070, AEU-1070-70V DENTAL IMPLANT MOTOR SYSTEM 70 NCM AEU-6000MIS-70V - IMPLANT SURGERY UNIT MIS W/AE-70V FOOTSWITCH AEU-6000SAU - IMPLANT SURGERY UNIT STERNGOLD AEU-6000SAU-70V - IMPLANT SURGERY UNIT STERNGOLD W/AE-70V FOOTSWITCH AEU-28SYB-1 - SYBRON ENDODONTIC SYSTEM 815-1500 N AMER AND AUS AE-230A-40 - MOTOR/CABLE ASSY AE-230A-40 AEU-6000-70V -IMPLANT SURGERY UNIT W/AE-70V FOOTSWITCH AE-7PM - FOOTSWITCH ON/OFF 4 PIN MALE AEU-1070-70V - IMPLANT SURGERY SYSTEM TOUCH SCREEN 70NCM W/AE-70V FOOTSWITCH AE-70V2SWM - FOOTSWITCH VARIABLE IMPLANT V2 SWM AE-70V2-GLI - FOOTSWITCH VARIABLE IMPLANT V2 GLIDEWELL AE-70V2 - FOOTSWITCH VARIABLE IMPLANT V2 AEU-6000-OCO-70V - IMPLANT SURGERY UNIT OCO BIOMEDICAL W/AE-70V FOOTSWITCH AE-70V2-10 - FOOTSWITCH VARIABLE IMPLANT V2 W/10FT CABLE AEU-6000PDR-70V - IMPLANT SURGERY UNIT PDR W/AE-70V FOOTSWITCH AE-23-10 - TUBING SET 10 FT AEU-7000 BAG AEU-1000, AEU-1000-70V DENTAL IMPLANT MOTOR SYSTEM 50 NCM AE-24-BOT - TUBING SET AEU-1000 BOTTLE AEU-1070 - IMPLANT SURGERY SYSTEM TOUCH SCREEN 70NCM W/AE-7PM FOOTSWITCH AEU-6000MG - IMPLANT SURGERY UNIT MEGAGENIMPLANT

    Establishment Types

    Manufacture Medical Device