BEUDAMED
    FDA Registration Active 🇩🇴 Dominican Republic

    300-021365-00 Monarch Controller Equipment Drape, Clamshell

    Reg #: 3010193531 · FEI: 3010193531 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    53
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    DAS MEDICAL INTERNATIONAL, SRL
    Registration Number
    3010193531
    FEI Number
    3010193531
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Industrial Free Zone II
    City
    La Romana
    Country
    DO

    Owner / Operator

    Firm Name
    UFP Technologies, Inc
    Operator Number
    10036300
    Address
    100 Hale Street
    City
    Newburyport
    State
    MA
    Postal Code
    01950
    Country
    US

    US Agent

    Business Name
    UFP Technologies, Inc.
    Contact Name
    Rolando Ardon
    Address
    100 Hale Street
    City
    Newburyport
    State
    MA
    ZIP
    01950
    Country
    US
    Email
    [email protected]
    Phone
    978 2340917

    Products

    Device Name Product Code
    Drape, Surgical, Exempt PUI

    Proprietary Names

    300-021365-00 Monarch Controller Equipment Drape, Clamshell OR2-SIS-Drape 300-008065-00 Equipment Cover CFG Drape X9007768 Senhance Arm Drape, W/ Verification Card X0008236 Sterile Tape SB-T1-01 Surgibubble Drape NAUDRPS Banded Bag Dome Kit X9007760 Senhance Articulating Drape OTT420-12 ETHICON 3-ARM STERILE DRAPE SYS-028 DrillCover SteriGo 4th Arm Drape SD-XSR66 Surgical Solution Warming Drape 44” x 66” SD-XDISC66 Surgical Solution Warming Drape- Slush Disc 300-008066-00 PAU Sheath Stabilizer Drape PB-5000 OtoShield Protective Barrier Drape 210-002933-00 Cart Equipment Monarch Drape MRASA0006V02 Robotic Arm Sterile Drape (8EA/CS) MRASA0006 Robotic Arm Sterile Drape BVACCE1-000045 Camera Head Drape 9” x 125 1/2” MRASA0008V02 Robotic Lower Arm Cart Sterile Drape (60/CS) X9007636 Senhance Arm Cover, 3 Pack COLUMN DRAPE IS4000 MRASA0007V01 Robotic Upper Arm Cart Sterile Drape (16EA/CS) X0007790 Senhance Articulating Drape X9007635 Senhance Arm Drape, Single Pack DR3500 User Interface Drape VISION PROBE BAG, IF1000 X9007669 Senhance Articulating Drape CA60105T C-Arm Drape DC-14-001 C-Arm Drape SD-XSR66W Surgical Solution Warming Drape 48” x 66” SD-CIR44 Round Basin Drape Assembly MRASA0007V02 Robotic Upper Arm Cart Sterile Drape(16EA/CS) BVACCE1-000024 Camera Head Drape 9” x 125 1/2” MRASA0007 Robotic Upper Arm Cart Sterile Drape OTT421-12 Assembly, Stowage Drape MRASA0006V01 Robotic Arm Sterile Drape (8EA/CS) X9007769 Senhance Manipulator Arm Drape w/verification Card, 3 Pack SD-DISC48 48x48 Slush Only Drape SD-XSR44 Solution Warming Drape 44” x 44” SD-DISC66 Combo Drape Assembly MUR-000013 Monarch Drape Kit DI 5114 Half Bag C-Arm Cover 36” x 80” SD-REC60 Solution Warming Drape Extended Frame 44” X 60” OTT420-13 Package Assembly, Drape ACC-002 Stylus Cover SD-REC44 Rectangular Basin Drape Assembly 700003337553 Mako Drape Kit MRASA0008 Robotic Lower Arm Cart Sterile Drape X9007763 Senhance USB-C LIA Cable SD-DISC66W Surgical Warming and Slush Drape 48” x 66” MRASA0008V01 Robotic Lower Arm Cart Sterile Drape (60/CS) 300-008064-00 Equipment Drape Monarch Controller

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device