FDA.reportPublic FDA data

Acessa Pads

Primary DI
00854763006102
Brand
Acessa Pads
Company
ACESSA HEALTH INC.
Model
3000
Device description
Acessa Pads, disposable dispersive pad, connects to the Acessa ProVu ConsoleLegacy #854763006010
Published
2018-10-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
00854763006102PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854763006102008547630061028547630061020854763006102

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
Lot or batch
true
Expiration 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
00854763006232Acessa ProVu System71002018-10-11
00854763006119Acessa Pad Cable43002018-10-11
00854763006256Acessa ProVu Dual Foot Pedal MS-06-01712020-12-07

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