FDA.reportPublic FDA data

Macan

Primary DI
00851683006397
Brand
Macan
Company
Macan Manufacturing
Model
R-C55
Device description
R-C55 Electrode (2 pk)
Published
2016-11-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
K052622000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052622000MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNITMacan Engineering Co.2005-12-09EKZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851683006397PrimaryGS10
00851708006739Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851683006397008516830063978516830063970851683006397
00851708006739008517080067398517080067390851708006739

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter0.0625Inch

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
(302) 645-8068info@macanmanufacturing.com

Regulatory Flags#

DUNS number
962296062
Device count
2
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851683006007Macan MC-6A2016-11-09
00851683006014MacanMC-4A2016-11-09
00851683006052MacanMC-6A (230V)2016-11-09
00851683006069MacanMC-4A (230V)2016-11-09
00851683006090MacanMC-6A 2016-11-09
00851683006106MacanMC-4A2016-11-09
00851683006137MacanMC-6B2018-10-25
00851683006144MacanMC-6A - 230V (individual unit)2016-11-09
00851683006151MacanMC-4A2016-11-09
00851683006182MacanADP2016-11-09
00851683006199MacanBCO2016-11-09
00851683006205MacanBPF-C12016-11-09
00851683006212MacanBPF-C22016-11-09
00851683006229MacanBPF-S12016-11-09
00851683006236MacanBPF-S22016-11-09
00851683006243MacanDPC-22016-11-09
00851683006250MacanDPP-12016-11-09
00851683006267MacanFDP-12016-11-09
00851683006274MacanHPAC-12016-11-09
00851683006281MacanCHPAC-12016-11-09

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