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.
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
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
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
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
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 90 |