FDA.reportPublic FDA data

Parkell

Primary DI
00810000526703
Brand
Parkell
Company
PARKELL, INC.
Model
AP-1 1/2
Catalog number
S397-AP1.5
Device description
AP-1 1/2 Electrosurge Electrode
Published
2018-09-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M595S397AP150PreviousHIBCC0
00810000526703PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810000526703008100005267038100005267030810000526703

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery electrosurgical electrode, monopolar, reusableAn invasive, monopolar, electrical conductor intended to be attached to an electrosurgical handpiece (not included) to deliver electrosurgical current directly to tissues for cutting/coagulation during an open surgical procedure. It may be available in a variety of forms (e.g., blade, ball, loop, needle, spatula) and requires a patient contact return electrode to complete the circuit. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
6312491134customerservice@parkell.com

Regulatory Flags#

DUNS number
009900424
Device count
1
DM exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M595S367UD1Epic®S367UDS367UD2016-09-23
M595S4130NAS413S4132016-09-23
00810000529568TotalBond®S413S4132018-11-23
00810000522729GentleCLEAN™DSG30GCPDSG30GCP2018-11-02
10810000527554Parkell®S276S2762018-10-19
M595S3930NAS393S3932016-09-23
M595S3940NAS394S3942016-09-23
M595S3950C&B METABOND®S395S3952016-09-23
00810000529070C&B METABOND®S394S3942018-11-23
00810000529193C&B METABOND®S393S3932018-11-23
00810000529209C&B METABOND®S395S3952018-11-23
00810000525294SmarTemp®S338S3382018-10-26
1081000052669420/20™S575S5752025-09-26
00810000525782HyperFIL®S235SPS235SP2025-09-26
00810000528271TriPhasix™S408S4082025-09-26
0081000052669720/20™S575S5752025-09-26
M595D6750Aurora™D675D6752016-09-24
00810000520053Parkell®D675D6752018-11-16
00810000522934DuraTip®DURA30-PSLDURA30-PSL2025-07-18
00810000522941DuraTip®DURA30-PSRDURA30-PSR2025-07-18

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