FDA.reportPublic FDA data

Ultravision2 IonPencil

Primary DI
05060417680498
Brand
Ultravision2 IonPencil
Company
ALESI SURGICAL LIMITED
Model
DPD-007-001
Catalog number
DPD-007-001
Device description
The Ultravision2 IonPencil™ is a bifunctional open surgery device that combines proprietary smoke management (via visual field clearing) and monopolar HF tissue cutting and coagulation in a single device. It’s addition to the Ultravision2 System adds the general open procedure capability to the Ultravision2™ indications of use along with the new single use accessory.
Published
2024-08-20
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
K240868000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240868000Ultravision2™ IonPencilAlesi Surgical Limited2024-08-12PQM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15060417680495PackageGS140In Commercial Distribution
25060417680492PackageGS12In Commercial Distribution
05060417680498PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1506041768049515060417680495
2506041768049225060417680492
05060417680498050604176804985060417680498

GMDN Terms#

Term, Definition table
TermDefinition
Surgical plume evacuation systemA mains electricity (AC-powered) assembly of devices intended to capture smoke generated during open surgical procedures involving tissue ablation (e.g., laser surgery, electrocautery, electrosurgical diathermy device). It captures the plume (smoke composed of carbonized cell fragments, water vapour, and hydrocarbons from vaporized tissue) near its origin before it becomes dispersed and causes surgical staff respiratory exposure. It consists of a capture tube or wand and four elements to evacuate smoke: user interface, filters, suction source, and exhaust. The system may be mobile (on wheels) and used during closed surgical procedures (e.g., endoscopy, laparoscopy) to clear the view. See also: Gas/fume evacuation system; Anaesthetic gas scavenging unit; Suction system filter, plume particulate; Orthopaedic cement fume evacuator; Surgical plume evacuation system tube

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

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
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
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

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