FDA.reportPublic FDA data

Geiger Thermal Cautery Unit

Primary DI
00609960001111
Brand
Geiger Thermal Cautery Unit
Company
DERMATOLOGIC LAB AND SUPPLY, INC.
Model
150
Catalog number
150
Device description
TCU, THERMAL CAUTERY, UNIT ONLY, 110v, 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

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K002341000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K002341000THERMAL CAUTERY UNIT, MODEL 150Geiger Medical Technologies, Inc.2000-10-23HQO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00609960001111PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00609960001111006099600011116099600011110609960001111

GMDN Terms#

Term, Definition table
TermDefinition
Electrocautery system generator, line-poweredA mains electricity (AC-powered) device that regulates an electrical current used to heat the electrode tip or wire loop of a cutting instrument used during surgical intervention to burn or sear body tissue. It is used to stop bleeding (cauterization of blood vessels), to treat superficial skin lesions, e.g., the removal of warts, the removal of gastrointestinal polyps via an appropriate endoscope or to occlude fallopian tubes during sterilization procedures. It will typically contain electronic circuits and have a built-in thermocoupler to help control the temperature at the electrode. This is not an electrosurgical diathermy system.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021628771
Device count
1
Serial number
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
10609960001002Thermalite Disposable TCU ElectrodeDERMATOLOGIC 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
00609960001128Geiger Thermal Cautery UnitDERMATOLOGIC LAB AND SUPPLY, INC.HQO2018-07-10