FDA.reportPublic FDA data

Guidance field generator

Primary DI
00854763006065
Brand
Guidance field generator
Company
HALT MEDICAL, INC
Model
5200
Catalog number
5200
Device description
The Table Top Field Generator (TTFG) generates a magnetic field that is picked up by the magnetic guidance sensors
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HFGCoagulator, Laparoscopic, Unipolar (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HFGCoagulator, Laparoscopic, Unipolar (And Accessories)Obstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854763006065PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854763006065008547630060658547630060650854763006065

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

Contacts#

Phone, Email table
PhoneEmail
877-412-3828info@haltmedical.com

Regulatory Flags#

DUNS number
602783495
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854763006003Handpiece200020002016-09-19
00854763006010Pads300030002016-09-19
00854763006027Handpiece cable420042002016-09-19
00854763006034Generator100010002016-09-19
00854763006072Pad cable430043002016-09-19
00854763006089Guidance handpiece530053002016-09-19
00854763006096Guidance handpiece cable540054002016-09-19
00854763006041Guidance controller510051002016-09-19
00854763006058Guidance ultrasound transducer sleeve550055002016-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15420045515260Acessa ProVu SystemHologic, Inc.HFG2024-09-13
15420045515277Acessa ProVu SystemHologic, Inc.HFG2024-09-13
15420045515291Acessa ProVu SystemHologic, Inc.HFG2024-09-13
15420045515246Acessa ProVu SystemHologic, Inc.HFG2023-05-16
15420045515253Acessa ProVu SystemHologic, Inc.HFG2023-05-16
15420045515307Acessa ProVu SystemHologic, Inc.HFG2023-05-16
15420045515314Acessa ProVu SystemHologic, Inc.HFG2023-05-16
15420045515284Acessa ProVu SystemHologic, Inc.HFG2022-11-08
00854763006256Acessa ProVu Dual Foot Pedal ACESSA HEALTH INC.HFG2020-12-07
14042761086278OlympusOLYMPUS Winter & Ibe GmbHHFG2020-07-31
00854763006102Acessa PadsACESSA HEALTH INC.HFG2018-10-11
00854763006119Acessa Pad CableACESSA HEALTH INC.HFG2018-10-11
00854763006126Acessa Table Top Field GeneratorACESSA HEALTH INC.HFG2018-10-11
00854763006140Acessa ProVu HandpieceACESSA HEALTH INC.HFG2018-10-11
00854763006157Acessa ProVu Handpiece CableACESSA HEALTH INC.HFG2018-10-11
00854763006188Acessa ProVu Transducer with sensorACESSA HEALTH INC.HFG2018-10-11
00854763006195Acessa ProVu Planar Field Generator (PFG)ACESSA HEALTH INC.HFG2018-10-11
00854763006232Acessa ProVu SystemACESSA HEALTH INC.HFG2018-10-11
00854763006249Acessa ProVu PFG Table ClampACESSA HEALTH INC.HFG2018-10-11
30653405009652CONMEDConmed CorporationHFG2016-09-24
30653405009669CONMEDConmed CorporationHFG2016-09-24
30653405009676CONMEDConmed CorporationHFG2016-09-24
30653405009683CONMEDConmed CorporationHFG2016-09-24
30653405009744CONMEDConmed CorporationHFG2016-09-24
30653405009768CONMEDConmed CorporationHFG2016-09-24
30653405009775CONMEDConmed CorporationHFG2016-09-24
30653405009782CONMEDConmed CorporationHFG2016-09-24
30653405009799CONMEDConmed CorporationHFG2016-09-24
30653405034449CONMEDConmed CorporationHFG2016-09-24
30653405034784NAConmed CorporationHFG2016-09-24