FDA.reportPublic FDA data

"Delasco 1/16"" Reusable Electrodes"

Primary DI
00609960001210
Brand
"Delasco 1/16"" Reusable Electrodes"
Company
DERMATOLOGIC LAB AND SUPPLY, INC.
Model
507G
Catalog number
507G
Device description
ELECTRODE, 1/8in (3mm) BALL, 1/16in SHAFT, DELASCO. 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
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K010025000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K010025000ELECTRICATOR MODEL 26000Dermatologic Lab & Supply, Inc.2001-02-22GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00609960001210PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00609960001210006099600012106099600012100609960001210

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

Regulatory Flags#

DUNS number
021628771
Device count
1
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

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Primary DI, Brand, Company table
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