FDA.reportPublic FDA data

Thermalite Disposable TCU Electrode

Primary DI
10609960001002
Brand
Thermalite Disposable TCU Electrode
Company
DERMATOLOGIC LAB AND SUPPLY, INC.
Model
212
Catalog number
212
Device description
THERMALITE DISPOSABLE TCU TIPS, ANGLED LOOP,BOX/10. Medical Device.
Published
2018-07-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
HQOUnit, Cautery, Thermal, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQOUnit, Cautery, Thermal, Ac-PoweredOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10609960001002PrimaryGS10
00609960001005Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060996000100210609960001002
00609960001005006099600010056099600010050609960001005

GMDN Terms#

Term, Definition table
TermDefinition
Electrocautery system electrodeAn active conductor (e.g., blade or loop) that is attached to an electrocautery system handpiece or other surgical instrument (e.g., an endoscopic device) which is heated via the electrical current from the generator and used during surgical intervention to burn or sear body tissue. It is made of an appropriate metal and is typically used to stop bleeding (cauterization of blood vessels) and to treat superficial skin lesions (e.g., removal of warts). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
021628771
Device count
10
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00609960000190Delasco 734 Handpiece734/H2016-05-13
00609960000251Delasco Electricator26000260002016-05-19
00609960000268ELECTRICATOR HANDPIECE26300263002016-05-19
10609960000012Delasco Biopsy SutureBDL-40B2015-11-02
10609960000029Delasco Biopsy SutureBDL-50B2015-11-02
10609960000036Delasco Biopsy SutureBDL-60B2015-11-02
10609960000043Delasco Biopsy SutureMS-40B2015-11-02
10609960000050Delasco Biopsy SutureMS-50B2015-11-02
10609960000067Delasco Biopsy SutureMS-60B2015-11-02
00609960001326Smoke Evacuator FilterEV-I/REV-I/R2020-09-30
00609960001302SaftEvacEV-IEV-I2020-09-16
00609960001296Delasco SaftEvac FilterEV/XEV/X2020-08-04
00609960000282Delasco Electricator Reusable Patient Plate26900269002016-06-15
00609960001289Segal ElectrodeSE/G1SE/G2019-12-31
10609960000135ElectroTipsET-1012016-05-13
10609960000142ElectroTipsET-1022016-05-13
10609960000159ElectroTipsET-1032016-05-13
10609960000166ElectroTipsET-1042016-05-13
10609960000173Electrolite262002016-05-13
10609960000180Electrolite26200S2016-05-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10609960000852Geiger TCU Cautery SheathDERMATOLOGIC LAB AND SUPPLY, INC.HQO2018-07-10
10609960000999Thermalite Disposable TCU ElectrodesDERMATOLOGIC LAB AND SUPPLY, INC.HQO2018-07-10
10609960001019Thermalite Disposable TCU ElectrodeDERMATOLOGIC LAB AND SUPPLY, INC.HQO2018-07-10
00609960000787Geiger Thermal Cautery UnitDERMATOLOGIC LAB AND SUPPLY, INC.HQO2018-07-10
00609960000794Geiger Thermal Cautery UnitDERMATOLOGIC LAB AND SUPPLY, INC.HQO2018-07-10
00609960000800Geiger Thermal Cautery UnitDERMATOLOGIC LAB AND SUPPLY, INC.HQO2018-07-10
00609960000817Geiger Thermal Cautery UnitDERMATOLOGIC LAB AND SUPPLY, INC.HQO2018-07-10
00609960000824Geiger TCU HandpieceDERMATOLOGIC LAB AND SUPPLY, INC.HQO2018-07-10
00609960000831Geiger TCU HandpieceDERMATOLOGIC LAB AND SUPPLY, INC.HQO2018-07-10
00609960000848Geiger TCU 100 HandpieceDERMATOLOGIC LAB AND SUPPLY, INC.HQO2018-07-10
00609960000862Geiger Reusable TCU ElectrodeDERMATOLOGIC LAB AND SUPPLY, INC.HQO2018-07-10
00609960000879Geiger Reusable TCU ElectrodeDERMATOLOGIC LAB AND SUPPLY, INC.HQO2018-07-10
00609960000886Geiger Resuable TCU ElectrodeDERMATOLOGIC LAB AND SUPPLY, INC.HQO2018-07-10
00609960000893Geiger TCU Reusable ElectrodeDERMATOLOGIC LAB AND SUPPLY, INC.HQO2018-07-10
00609960000909Geiger Reusable TCU ElectrodeDERMATOLOGIC LAB AND SUPPLY, INC.HQO2018-07-10
00609960000916Geiger Reusable TCU ElectrodeDERMATOLOGIC LAB AND SUPPLY, INC.HQO2018-07-10
00609960000923Geiger Reusable TCU ElectrodeDERMATOLOGIC LAB AND SUPPLY, INC.HQO2018-07-10
00609960000930Geiger Reusable TCU ElectrodeDERMATOLOGIC LAB AND SUPPLY, INC.HQO2018-07-10
00609960000947Geiger Reusable TCU ElectrodeDERMATOLOGIC LAB AND SUPPLY, INC.HQO2018-07-10
00609960000954Geiger Reusable TCU ElectrodeDERMATOLOGIC LAB AND SUPPLY, INC.HQO2018-07-10
00609960000961Geiger Reusable TCU ElectrodeDERMATOLOGIC LAB AND SUPPLY, INC.HQO2018-07-10
00609960000978Geiger Reusable TCU ElectrodeDERMATOLOGIC LAB AND SUPPLY, INC.HQO2018-07-10
00609960000985Geiger Reusable TCU ElectrodeDERMATOLOGIC LAB AND SUPPLY, INC.HQO2018-07-10
00609960001036Geiger Reusable TCU ElectrodeDERMATOLOGIC LAB AND SUPPLY, INC.HQO2018-07-10
00609960001043Geiger Reusable TCU ElectrodeDERMATOLOGIC LAB AND SUPPLY, INC.HQO2018-07-10
00609960001050Geiger Reusable TCU ElectrodeDERMATOLOGIC LAB AND SUPPLY, INC.HQO2018-07-10
00609960001067Geiger Reusable TCU ElectrodesDERMATOLOGIC LAB AND SUPPLY, INC.HQO2018-07-10
00609960001104Geiger Reusable TCU ElectrodeDERMATOLOGIC LAB AND SUPPLY, INC.HQO2018-07-10
00609960001111Geiger Thermal Cautery UnitDERMATOLOGIC LAB AND SUPPLY, INC.HQO2018-07-10
00609960001128Geiger Thermal Cautery UnitDERMATOLOGIC LAB AND SUPPLY, INC.HQO2018-07-10