FDA.reportPublic FDA data

T2 Small loop electrode

Primary DI
04719873120475
Brand
T2 Small loop electrode
Company
BONART CO., LTD.
Model
T2
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EKZUnit, Electrosurgical, And Accessories, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKZUnit, Electrosurgical, And Accessories, DentalDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K020080000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K020080000BONART ART-E1 ELECTROSURGERY UNITDiagnostic Data, Inc.2002-02-19EKZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719873120475PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719873120475047198731204754719873120475

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical systemAn assembly of devices intended to generate, and apply radio-frequency (RF) alternating current to soft tissues for cutting and coagulation during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues (i.e., not a radio-frequency ablation system). The assembly includes a mains electricity-powered (AC-powered) RF generator with monitoring functions/controls, connection cables, a handpiece, and electrodes to apply the energy to the surgical site. Tissue resistance to the electrical current creates the heat as the current travels through the body between electrodes; it is not intended for argon-enhanced electrosurgery.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
657263687
Device count
1
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719873121854ARTART-P3II PRO2026-04-27
04719873121861ARTART-M3II PRO2026-04-27
04719873121281GT1 Blade Type ElectrodeGT12020-02-27
04719873121298GT2 Small Loop ElectrodeGT22020-02-27
04719873121304GT3 Large Loop ElectrodeGT32020-02-27
04719873121311GT4 Fine Wire ElectrodeGT42020-02-27
04719873121328GT5 Heavy Wire ElectrodeGT52020-02-27
04719873121335GT8 Heavy Ball Electrode (2.38mm)GT82020-02-27
04719873121342GT9 Heavy Ball Electrode (5mm)GT92020-02-27
04719873120048ELECTROSURGERY SYSTEMART-E1 2016-09-20
04719873120161E1 Hand Piece731201612016-09-20
04719873120178E1 Indifference plate EU0004-002R 2016-09-20
04719873120185E1 electrode set (7 tips)731201852016-09-20
04719873120468T1 Diamond shaped electrodeT12016-09-20
04719873120482T3 Large loop electrodeT32016-09-20
04719873120499T4 Fine wire electrodeT4 2016-09-20
04719873120505T5 Heavy wire electrodeT52016-09-20
04719873120512T7 Fine oval loop electrodeT72016-09-20
04719873120529T9 Heavy ball electrodeT9 2016-09-20
04719873121212E1 INDIFFERENCE PLATE ∮ 6.3mmEU0004-062RH2018-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04548213056545Root ZX3J.MORITA MFG.CORP.EKZ2023-06-27
00810000520046Sensimatic®PARKELL, INC.EKZ2021-12-10
00810000520107Sensimatic™PARKELL, INC.EKZ2021-12-10
04719873121281GT1 Blade Type ElectrodeBONART CO., LTD.EKZ2020-02-27
04719873121298GT2 Small Loop ElectrodeBONART CO., LTD.EKZ2020-02-27
04719873121304GT3 Large Loop ElectrodeBONART CO., LTD.EKZ2020-02-27
04719873121311GT4 Fine Wire ElectrodeBONART CO., LTD.EKZ2020-02-27
04719873121328GT5 Heavy Wire ElectrodeBONART CO., LTD.EKZ2020-02-27
04719873121335GT8 Heavy Ball Electrode (2.38mm)BONART CO., LTD.EKZ2020-02-27
04719873121342GT9 Heavy Ball Electrode (5mm)BONART CO., LTD.EKZ2020-02-27
00810000520749Sensimatic®PARKELL, INC.EKZ2020-02-07
00810000520718Sensimatic®PARKELL, INC.EKZ2019-08-16
04719873121250E1 Indiference Plate BONART CO., LTD.EKZ2019-02-28
04719873121267ART GT E1 Electrode SetBONART CO., LTD.EKZ2019-02-28
00810000520695Sensimatic®PARKELL, INC.EKZ2018-11-16
00810000520725Sensimatic®PARKELL, INC.EKZ2018-11-16
00810000520732Sensimatic®PARKELL, INC.EKZ2018-11-16
04719873121236E1 Handpiece (L)BONART CO., LTD.EKZ2018-11-05
04719873121243E1 Handpiece (S)BONART CO., LTD.EKZ2018-11-05
00853404007515MacanMacan ManufacturingEKZ2018-10-25
04719873121212E1 INDIFFERENCE PLATE ∮ 6.3mmBONART CO., LTD.EKZ2018-09-21
04719873121229METAL GROUNDING PLATE & CORDBONART CO., LTD.EKZ2018-09-21
00810000520763Sensimatic™PARKELL, INC.EKZ2018-09-21
00810000520770Sensimatic™PARKELL, INC.EKZ2018-09-21
00810000520701Sensimatic™PARKELL, INC.EKZ2018-09-14
00810000526710Parkell®PARKELL, INC.EKZ2018-09-14
00810000526727Parkell®PARKELL, INC.EKZ2018-09-14
00810000526734Parkell®PARKELL, INC.EKZ2018-09-14
00810000526741Parkell®PARKELL, INC.EKZ2018-09-14
00810000526758Parkell®PARKELL, INC.EKZ2018-09-14