Control handle

Primary DI
03665772000015
Brand
Control handle
Company
DEX SURGICAL
Model
P-1301
Device description
The DEX Device control handle is comprised of an ergonomic hand piece that can turn on its own axis thanks to the comfort joint. This axis can also allow the user to perform a complete manual prono-supination movement without moving his shoulder.The control handle has command buttons that activate the different degrees of freedom or the Arm. The three axes are motorized: Open/Close, Tilt (Left/Right), Rotation+/Rotation-.
Published
2022-05-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191878000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191878000DEX DeviceDex Surgical2021-01-29GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03665772000015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03665772000015036657720000153665772000015

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electromechanical surgical systemAn assembly of mains electricity (AC-powered) electromechanical devices designed to be used to perform an endoscopic surgical procedure (e.g., laparoscopy) via hand-held rigid endoscopic instruments that have motor-driven articulating and mechanically-operated tips intended to facilitate surgical dexterity. It typically consists of a control unit that provides power via connecting cables to individual handpieces (handles) and several interchangeable endoscopic instruments with tip articulation (e.g., roll, yaw) for performing tissue manipulation, ligation, suturing, and cutting. The system is connected to a visual display unit (VDU) and is typically mounted on a trolley (cart) for mobility.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
268845728
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03665772000008 Control UnitE-13012022-05-06
03665772000022 Control Handle LeftP-13022022-05-06
03665772000039 Protection sleeve2090-MDS2022-05-06
03665772000046Monopolar protection sleeveM-13042022-05-06
03665772000053Sleeve applicator toolP46732 2022-05-06
03665772000060 Arm Needle holderB-13012022-05-06
03665772000077 Arm Monopolar scissorsB-13042022-05-06
03665772000084Arm Monopolar MarylandB-1505 2022-05-06
03665772000091Arm Monopolar hookB-1506 2022-05-06

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