UltravisionTM

Primary DI
05060417680245
Brand
UltravisionTM
Company
ALESI SURGICAL LIMITED
Model
Mains Converter
Catalog number
DAD-004-012
Device description
UltravisionTM Visual Field Clearing System
Published
2018-11-30
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
PQMSurgical Smoke Precipitator

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182053000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182053000Ultravision™ Visual Field Clearing SystemAlesi Surgical, Ltd.2018-09-07PQM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060417680245PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060417680245050604176802455060417680245

GMDN Terms#

Term, Definition table
TermDefinition
Surgical fluid/smoke waste management systemAn assembly of devices designed to collect and dispose of both surgical fluid waste and plume smoke generated by surgical procedures involving electrosurgical diathermy, electrocautery, or a laser. It typically consists of a mains electricity (AC-powered) mobile suction unit and a fixed disposal unit. The suction unit uses negative pressure at the site of intervention to collect/filter the fluid/smoke in its containers and filters; it is attached to the disposal unit for automatic container emptying and cleaning. The system is used in the operating room (OR), pathology and surgical centres, and doctor's offices to minimize healthcare worker exposure to harmful fluids/smoke.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
219516254
Device count
1
Serial number
true
Manufacturing date on label
true

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
15060417680419Ultravision2 GeneratorDPD-006-001DPD-006-0012023-12-13
35060417680468Ultravision2 Integrated Monopolar L Hook (H/S)DPD-006-201DPD-006-2012023-12-13
05060417680214UltravisionTMUltravision TM 5mm TrocarDAD-003-0132017-07-14
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
15060417680419Ultravision2 GeneratorALESI SURGICAL LIMITEDPQM2023-12-13
35060417680468Ultravision2 Integrated Monopolar L Hook (H/S)ALESI SURGICAL LIMITEDPQM2023-12-13
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