Ultravision2 Integrated Monopolar L Hook (H/S)

Primary DI
05060417680467
Brand
Ultravision2 Integrated Monopolar L Hook (H/S)
Company
ALESI SURGICAL LIMITED
Model
DPD-006-201
Catalog number
DPD-006-201
Device description
The Integrated Monopolar L-Hook (H/S)™ is a bifunctional device that combines proprietary visual field clearing and monopolar HF tissue and coagulation in a single device. The Integrated Monopolar L-Hook (H/S)™ can only interface with the Ultravision2 generator which connects directly to a commercially available electrosurgical generator (ESU) for its HF monopolar energy source. The Integrated Monopolar L-Hook (H/S)™ provides two recessed smoke clearing emitters that are automatically activated to clear the visual field when the device cutting function (HF) is activated.The mode of action of visual field clearing is electrostatic precipitation as per the predicate Ultravision system. When the tissue cutting is ceased, the visual field clearing signal is automatically switched off after a short delay period that is settable on the Ultravision 2 generator user interface.Activation of the HF function of the Integrated Monopolar L-Hook (H/S)™ is via a yellow (Cut) or blue (Coag) button located on the handpiece, or via a footswitch if this connected to the parent electrosurgical generator which is connected to the Ultravision 2 system. The Integrated Monopolar L-Hook (H/S)™ itself is incompatible with the connectors of third party electrosurgical generators.On demand visual field clearing only can also be applied by activation of a third grey button on the handle. This clearing field action is stopped immediately after release of the grey button.
Published
2023-12-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories
PQMSurgical Smoke Precipitator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2
PQMSurgical Smoke PrecipitatorGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231298000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231298000Ultravision2™ System Integrated Monopolar L-Hook (H/S)™Alesi Surgical, Ltd.2023-10-31PQM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15060417680464PackageGS15In Commercial Distribution
25060417680461PackageGS14In Commercial Distribution
35060417680468PackageGS11In Commercial Distribution
05060417680467PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1506041768046415060417680464
2506041768046125060417680461
3506041768046835060417680468
05060417680467050604176804675060417680467

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.

Contacts#

Phone, Email table
PhoneEmail
+4402920291022pravinpatel@alesi-surgical.com

Regulatory Flags#

DUNS number
219516254
Device count
1
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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15060417680419Ultravision2 GeneratorDPD-006-001DPD-006-0012023-12-13
35060417680468Ultravision2 Integrated Monopolar L Hook (H/S)DPD-006-201DPD-006-2012023-12-13
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05060417680061UltravisionTMPatient Return Adaptor 0.75m (Split)DAD-001-0072017-05-12
05060417680122UltravisionTMPatient Return Adaptor 1.5M (solid)DAD-001-0292017-05-12
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