| Primary Device ID | 03665772000046 |
| NIH Device Record Key | 607ef8ca-39a2-4f8d-a9f8-718bad7d16ff |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Monopolar protection sleeve |
| Version Model Number | M-1304 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 03665772000046 [Primary] |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[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
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-05-16 |
| Device Publish Date | 2022-05-06 |
| 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 | 2022-05-16Monopolar 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 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 |