FDA.reportPublic FDA data

Acessa Table Top Field Generator

Primary DI
00854763006126
Brand
Acessa Table Top Field Generator
Company
ACESSA HEALTH INC.
Model
5200
Device description
Acessa Table Top Field Generator (TTFG), connects to the Acessa ProVu Console. Includes TTFG Pad Set
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
00854763006126PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854763006126008547630061268547630061260854763006126

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
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00854763006102Acessa Pads30002018-10-11
00854763006119Acessa Pad Cable43002018-10-11
00854763006256Acessa ProVu Dual Foot Pedal MS-06-01712020-12-07

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Primary DI, Brand, Company table
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00841517112028iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
00841517112035iLOOKFUJIFILM SONOSITE, INC.IYO2026-07-16
00841517112035iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
00841517112462iLOOKFUJIFILM SONOSITE, INC.IYO2026-07-16
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00841517139018iLOOKFUJIFILM SONOSITE, INC.IYO2026-07-16
00841517139018iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
00860013043605EdgeLife TechnologiesEdge Life Technologies, LLCITX2026-07-10
00860013043605EdgeLife TechnologiesEdge Life Technologies, LLCIYO2026-07-10
00860013043612EdgeLife TechnologiesEdge Life Technologies, LLCITX2026-07-10
00860013043612EdgeLife TechnologiesEdge Life Technologies, LLCIYO2026-07-10
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00841517112653rP19x/5-1 MHz ArmoredFUJIFILM SONOSITE, INC.IYO2026-06-24
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00841517112660L12-3FUJIFILM SONOSITE, INC.ITX2026-06-24
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00852619008041QT Scanner 2000Qt Imaging, Inc.IYO2026-06-24
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00841517112646L15-4FUJIFILM SONOSITE, INC.IYO2026-06-23
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