Monopolar protection sleeve

GUDID 03665772000046

Monopolar protection sleeve is designed to be installed onto Monopolar Arms B-1304, B-1505 and B-1506 and to remain there for the duration of the surgical procedure. It is provided non-sterile and is single use; it must be sterilize before the use. Its purpose is to protect the gear mechanism from its environment and guarantee the electrical insulation. It prevents the distal part of the arms (except for the tip) from coming into contact with the patient's tissues, thereby preventing the risk of lesions and burning subsequent to such contact.

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 ID03665772000046
NIH Device Record Key607ef8ca-39a2-4f8d-a9f8-718bad7d16ff
Commercial Distribution StatusIn Commercial Distribution
Brand NameMonopolar protection sleeve
Version Model NumberM-1304
Company DUNS268845728
Company NameDEX SURGICAL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103665772000046 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03665772000046]

Moist Heat or Steam Sterilization


[03665772000046]

Moist Heat or Steam Sterilization


[03665772000046]

Moist Heat or Steam Sterilization


[03665772000046]

Moist Heat or Steam Sterilization


[03665772000046]

Moist Heat or Steam Sterilization


[03665772000046]

Moist Heat or Steam Sterilization


[03665772000046]

Moist Heat or Steam Sterilization


[03665772000046]

Moist Heat or Steam Sterilization


[03665772000046]

Moist Heat or Steam Sterilization


[03665772000046]

Moist Heat or Steam Sterilization


[03665772000046]

Moist Heat or Steam Sterilization


[03665772000046]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-16
Device Publish Date2022-05-06

Devices Manufactured by DEX SURGICAL

03665772000008 - Control Unit2022-05-16 The console or control unit contains the DEX Device operating system. The front surface contains indicator lights, buttons, an
03665772000015 - Control handle2022-05-16 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 Left2022-05-16 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 sleeve2022-05-16 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 sleeve2022-05-16Monopolar protection sleeve is designed to be installed onto Monopolar Arms B-1304, B-1505 and B-1506 and to remain there for the duration of the surgical procedure. It is provided non-sterile and is single use; it must be sterilize before the use. Its purpose is to protect the gear mechanism from its environment and guarantee the electrical insulation. It prevents the distal part of the arms (except for the tip) from coming into contact with the patient's tissues, thereby preventing the risk of lesions and burning subsequent to such contact.
03665772000046 - Monopolar protection sleeve2022-05-16 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 tool2022-05-16 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 holder2022-05-16 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 scissors2022-05-16 The monopolar scissors are reusable (20 uses) endoscopic instrument. It is connected to the control handle and is used with the

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.