FDA.reportPublic FDA data

Acessa ProVu System

Primary DI
00854763006232
Brand
Acessa ProVu System
Company
ACESSA HEALTH INC.
Model
7100
Device description
Acessa ProVu System, Power Cord, Foot Pedal Assembly, Video Cable
Published
2018-10-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HFGCoagulator, Laparoscopic, Unipolar (And Accessories)
ITXTransducer, Ultrasonic, Diagnostic
IYOSystem, Imaging, Pulsed Echo, Ultrasonic
OEWTracking, Soft Tissue, Intraoperative

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HFGCoagulator, Laparoscopic, Unipolar (And Accessories)Obstetrics/Gynecology2
ITXTransducer, Ultrasonic, DiagnosticRadiology2
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2
OEWTracking, Soft Tissue, IntraoperativeNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854763006232PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854763006232008547630062328547630062320854763006232

GMDN Terms#

Term, Definition table
TermDefinition
Radio-frequency ablation systemAn assembly of devices designed to generate and apply radio-frequency (RF) electrical current for heating via an electrode(s) in a precise location, at a controlled temperature, for focal ablation of non-cardiac tissues, including nerves, tumours, precancerous tissue; it may be intended for coagulation however it is not intended for electrosurgical cutting. It typically includes a mains electricity (AC-powered) RF current generator, controls, cables, and an appropriate electrosurgical ablation probe, catheter, and/or handpiece with electrode(s).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080935394
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854763006126Acessa Table Top Field Generator52002018-10-11
00854763006195Acessa ProVu Planar Field Generator (PFG)81002018-10-11
00854763006249Acessa ProVu PFG Table ClampMS-05-02572018-10-11
00854763006140Acessa ProVu Handpiece73002018-10-11
00854763006157Acessa ProVu Handpiece Cable74002018-10-11
00854763006188Acessa ProVu Transducer with sensor77002018-10-11
00854763006102Acessa Pads30002018-10-11
00854763006119Acessa Pad Cable43002018-10-11
00854763006256Acessa ProVu Dual Foot Pedal MS-06-01712020-12-07

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