Control Unit

GUDID 03665772000008

The console or control unit contains the DEX Device operating system. The front surface contains indicator lights, buttons, an emergency stop button and a connection port

DEX SURGICAL

Endoscopic electromechanical surgical system Endoscopic electromechanical surgical system Endoscopic electromechanical surgical system Endoscopic electromechanical surgical system Endoscopic electromechanical surgical system Endoscopic electromechanical surgical system Endoscopic electromechanical surgical system Endoscopic electromechanical surgical system Endoscopic electromechanical surgical system Endoscopic electromechanical surgical system Endoscopic electromechanical surgical system Endoscopic electromechanical surgical system

• Primary Device ID: 03665772000008
• NIH Device Record Key: 3bda95f7-eb3f-4248-8879-f52d8c6fd451
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Control Unit
• Version Model Number: E-1301
• Company DUNS: 268845728
• Company Name: DEX SURGICAL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03665772000008 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191878

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-16
• Device Publish Date: 2022-05-06

Devices Manufactured by DEX SURGICAL

• 03665772000008 - Control Unit: 2022-05-16The console or control unit contains the DEX Device operating system. The front surface contains indicator lights, buttons, an emergency stop button and a connection port
• 03665772000008 - Control Unit: 2022-05-16 The console or control unit contains the DEX Device operating system. The front surface contains indicator lights, buttons, an
• 03665772000015 - Control handle: 2022-05-16 The DEX Device control handle is comprised of an ergonomic hand piece that can turn on its own axis thanks to the comfort joint.
• 03665772000022 - Control Handle Left: 2022-05-16 The DEX Device control handle for left handed is comprised of an ergonomic hand piece that can turn on its own axis thanks to th
• 03665772000039 - Protection sleeve: 2022-05-16 Protection sleeve 2090-MDS is designed to be placed on the Needle holder arm and to remain there for the duration of the surgica
• 03665772000046 - Monopolar protection sleeve: 2022-05-16 Monopolar protection sleeve is designed to be installed onto Monopolar Arms B-1304, B-1505 and B-1506 and to remain there for th
• 03665772000053 - Sleeve applicator tool: 2022-05-16 The Sleeve applicator tool purpose is to help the installation of Protection sleeve 2090-MDS onto the tip of Arm Needle holder B
• 03665772000060 - Arm Needle holder: 2022-05-16 The arm needle holder is a reusable (40 uses) endoscopic instrument. It is connected to the control handle and is used with the
• 03665772000077 - Arm Monopolar scissors: 2022-05-16 The monopolar scissors are reusable (20 uses) endoscopic instrument. It is connected to the control handle and is used with the