Ultravision2 Generator

Primary DI
15060417680419
Brand
Ultravision2 Generator
Company
ALESI SURGICAL LIMITED
Model
DPD-006-001
Catalog number
DPD-006-001
Device description
The Ultravision2 System/Generator is designed to integrate surgical smoke clearing technology with the electrosurgical and ultrasonic systems that are used in electrosurgery. The UV2 Generator provides an interface between commercially available electrosurgical generators and electrosurgical instruments. The intention is to provide a system that enables the synchronization of Ionwand activation to clear the visual field with the energy output from electrosurgical or ultrasonic devices that generate the surgical smoke.
Published
2023-12-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
PQMSurgical Smoke Precipitator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PQMSurgical Smoke PrecipitatorGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231238000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231238000Ultravision2™ SystemAlesi Surgical, Ltd.2023-10-31PQM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15060417680419PackageGS11In Commercial Distribution
05060417680412PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1506041768041915060417680419
05060417680412050604176804125060417680412

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic plume filterA sterile device intended to be used during minimally-invasive surgery, in particular laparoscopic surgery, to filter surgical smoke (plume created by, e.g., electrosurgical diathermy, a laser or sonic scalpel) of potentially harmful agents (e.g., noxious chemicals, particulates, viruses, bacteria) without loss of pneumoperitoneum. It is typically a multi-layered filter pouch intended to be connected to a trocar stopcock; it is intended to help protect surgical staff from ambient exposure to potentially harmful agents. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+442920291022pravinpatel@alesi-surgical.com

Regulatory Flags#

DUNS number
219516254
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060417680207UltravisionTMIonwandTM Sterile PackDAD-001-0032017-05-12
05060417680009UltravisionTMUltravisionTM System Starter PackDAD-001-0152017-05-12
05060417680498Ultravision2 IonPencilDPD-007-001DPD-007-0012024-08-20
15060417680495Ultravision2 IonPencilDPD-007-001DPD-007-0012024-08-20
05060417680412Ultravision2 GeneratorDPD-006-001DPD-006-0012023-12-13
05060417680467Ultravision2 Integrated Monopolar L Hook (H/S)DPD-006-201DPD-006-2012023-12-13
35060417680468Ultravision2 Integrated Monopolar L Hook (H/S)DPD-006-201DPD-006-2012023-12-13
05060417680214UltravisionTMUltravision TM 5mm TrocarDAD-003-0132017-07-14
05060417680245UltravisionTMMains ConverterDAD-004-0122018-11-30
05060417680030UltravisionTMUltravsionTM Power Supply UnitDSD-001-0352017-05-12
05060417680078UltravisionTMPatient Return Adaptor 1.5M (solid)DAD-001-0292017-05-12
05060417680085UltravisionTMPatient Return Adaptor 1.5m (Split)DAD-001-0302017-05-12
05060417680016UltravisionTMUltravision Battery Recharging StationDAD-001-0242017-05-12
05060417680023UltravisionTMUltravisionTM GeneratorDAD-001-0102017-05-12
05060417680177UltravisionTMUltravsionTM Power Supply UnitDSD-001-0352017-05-12
05060417680047UltravsionTMUltravision Battery (x2)DSD-001-0342017-05-12
05060417680054UltravisionTMPatient Return Adaptor SolidDAD-001-0062017-05-12
05060417680061UltravisionTMPatient Return Adaptor 0.75m (Split)DAD-001-0072017-05-12
05060417680122UltravisionTMPatient Return Adaptor 1.5M (solid)DAD-001-0292017-05-12
05060417680139UltravisionTMPatient Return Adaptor 1.5m (Split)DAD-001-0302017-05-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060417680498Ultravision2 IonPencilALESI SURGICAL LIMITEDPQM2024-08-20
15060417680495Ultravision2 IonPencilALESI SURGICAL LIMITEDPQM2024-08-20
05060417680412Ultravision2 GeneratorALESI SURGICAL LIMITEDPQM2023-12-13
05060417680467Ultravision2 Integrated Monopolar L Hook (H/S)ALESI SURGICAL LIMITEDPQM2023-12-13
35060417680468Ultravision2 Integrated Monopolar L Hook (H/S)ALESI SURGICAL LIMITEDPQM2023-12-13
05060417680245UltravisionTMALESI SURGICAL LIMITEDPQM2018-11-30
05060417680214UltravisionTMALESI SURGICAL LIMITEDPQM2017-07-14
05060417680030UltravisionTMALESI SURGICAL LIMITEDPQM2017-05-12
05060417680078UltravisionTMALESI SURGICAL LIMITEDPQM2017-05-12
05060417680085UltravisionTMALESI SURGICAL LIMITEDPQM2017-05-12
05060417680207UltravisionTMALESI SURGICAL LIMITEDPQM2017-05-12
05060417680009UltravisionTMALESI SURGICAL LIMITEDPQM2017-05-12
05060417680016UltravisionTMALESI SURGICAL LIMITEDPQM2017-05-12
05060417680023UltravisionTMALESI SURGICAL LIMITEDPQM2017-05-12
05060417680177UltravisionTMALESI SURGICAL LIMITEDPQM2017-05-12
05060417680047UltravsionTMALESI SURGICAL LIMITEDPQM2017-05-12
05060417680054UltravisionTMALESI SURGICAL LIMITEDPQM2017-05-12
05060417680061UltravisionTMALESI SURGICAL LIMITEDPQM2017-05-12
05060417680122UltravisionTMALESI SURGICAL LIMITEDPQM2017-05-12
05060417680139UltravisionTMALESI SURGICAL LIMITEDPQM2017-05-12
25060417680201UltravisionTMALESI SURGICAL LIMITEDPQM2017-05-12