Delasco Electricator - DESCRIPTIONThe Delasco Electricator is a - DERMATOLOGIC LAB AND SUPPLY, INC.

Duns Number:021628771

Device Description: DESCRIPTIONThe Delasco Electricator is a non-sterile, reusable, electrosurgical generator. DESCRIPTIONThe Delasco Electricator is a non-sterile, reusable, electrosurgical generator. The Electricator is designed to generate high frequencies (radio frequency “RF”) of high voltage and low amperage current. The unit incorporates a ground-referenced monopolar and bipolar output which is used primarily in physician’s offices and treatment rooms to perform electrosurgical desiccation, fulguration, and coagulation procedures (described below). Patients with dermatological lesions such as cysts, polyps, and carbuncles can be treated with the Electricator with or without the use of anesthesia (depending on the site of the procedure and the patient tolerance level).INTENDED USEThe Delasco Electricator is intended to be utilized for destroying skin lesions and to coagulate small bleeders by applying high frequency current. The unit is used primarily in the Physician’s office and in particular, those of Dermatologists and Plastic Surgeons.

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More Product Details

Catalog Number

26000

Brand Name

Delasco Electricator

Version/Model Number

26000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Device Record Status

Public Device Record Key

15442ab9-bb15-424c-9d74-623a461a80e8

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

May 19, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DERMATOLOGIC LAB AND SUPPLY, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 90