DEVICE: Delasco Electricator (00609960000251)
Device Identifier (DI) Information
Delasco Electricator
26000
In Commercial Distribution
26000
DERMATOLOGIC LAB AND SUPPLY, INC.
26000
In Commercial Distribution
26000
DERMATOLOGIC LAB AND SUPPLY, INC.
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
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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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.
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FDA Product Code
[?]Product Code | Product Code Name |
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GEI | Electrosurgical, Cutting & Coagulation & Accessories |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
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No storage/handling found |
Clinically Relevant Size
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No Device Sizes |
Device Record Status
15442ab9-bb15-424c-9d74-623a461a80e8
April 04, 2023
3
May 19, 2016
April 04, 2023
3
May 19, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
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Secondary DI
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Unit of Use DI
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Unit of Use DI Number:
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CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined