FDA.reportPublic FDA data

Sensimatic®

Primary DI
00810000520718
Brand
Sensimatic®
Company
PARKELL, INC.
Model
D633CK
Catalog number
D633CK
Device description
Locking Chuck (only) for Sensimatic® Handpiece
Published
2019-08-16
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
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
00810000520718PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810000520718008100005207188100005207180810000520718

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical handpiece/electrode holder, reusableA device used to house or fix an active electrosurgical conducting unit (handpiece/pen with its electrode) when not being used by the surgeon during the surgical procedure. This is to secure the conducting unit, especially the electrode, within the sterile operating zone and protect it against potential adverse events. This device will typically be fastened to an object within the sterile field (e.g., a drape, anaesthesia dividing arm, operating table). This is a reusable device intended to be sterilized prior to use.

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
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
00810000526765Parkell®PARKELL, INC.EKZ2018-09-14