FDA.reportPublic FDA data

Handpiece cable

Primary DI
00854763006027
Brand
Handpiece cable
Company
HALT MEDICAL, INC
Model
4200
Catalog number
4200
Device description
Cable connects the handpiece to the generator
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00854763006027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854763006027008547630060278547630060270854763006027

GMDN Terms#

Term, Definition table
TermDefinition
Electromagnetic surgical navigation device tracking systemAn assembly of devices intended to provide a physician with an electromagnetic (EM) tool for image registration and/or tracking of manual surgical instruments typically with respect to pre-acquired images (e.g., CT/MRI scan) or real-time data [e.g., ultrasound (US)] during surgery. It consists of a workstation with controls/display, a line-powered EM field generator, a tracking unit, instruments and trackers with sensors/localizers, and adhesive skin markers. It is used for multiple surgical procedures (e.g., ethmoidectomy, tumour resection, fibroid ablation, biopsy, drilling, vascular access) in various fields [e.g., ENT, craniomaxillofacial (CMF), laparoscopic, or orthopaedic surgery].

Sterilization Methods#

Method table
Method
Hydrogen Peroxide

Regulatory Flags#

DUNS number
602783495
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854763006003Handpiece200020002016-09-19
00854763006010Pads300030002016-09-19
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
00854763006065Guidance field generator520052002016-09-19

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