Delasco Electricator
Basic Information
- Brand Name
- Delasco Electricator
- Primary DI
- 00609960000251
- Version / Model
- 26000
- Catalog Number
- 26000
- Company Name
- DERMATOLOGIC LAB AND SUPPLY, INC.
- Labeler DUNS
- 021628771
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-05-19
- Public Version
- 3
- Public Version Date
- 2023-04-04
- Public Version Status
- Update
- Public Device Record Key
- 15442ab9-bb15-424c-9d74-623a461a80e8
Device Description
DESCRIPTION The 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 USE The 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11490 | Electrosurgical system generator | An electrically-powered component of a electrosurgical system intended to generate radio-frequency (RF) electrical current for subsequent cutting and coagulation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues (i.e., not a radio-frequency ablation system generator). It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for inert gas-enhanced electrosurgery. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00609960000251 | GS1 |