REUSABLE ANGLED SHARP ELECTRODE

Basic Information

• Brand Name: REUSABLE ANGLED SHARP ELECTRODE
• Primary DI: 00192896009240
• Version / Model: A830
• Catalog Number: A830
• Company Name: SONTEC INSTRUMENTS, INC.
• Labeler DUNS: 040729840
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-08-16
• Public Version: 3
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: d98ebfb8-fed9-48a7-8d4b-cd9a23f3c2de
• Distribution End Date: 2020-10-16

Device Description

REUSABLE ANGLED SHARP ELECTRODE

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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: ["Moist Heat or Steam Sterilization", "Dry Heat Sterilization"]

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
61098	Syringe-loaded medication/vaccine injector, electropneumatic	A hand-held, mains electricity (AC-powered) and pneumatically-powered (i.e., electropneumatic) device intended to be used in conjunction with a standard plunger syringe and needle for intradermal administration of liquid medications/materials (e.g., dermal reconstructive material) to a preselected depth; it is not intended for subcutaneous or intramuscular injection. It is typically a pistol-shaped device which includes a syringe loading chamber, a mechanism for precise displacement of the syringe plunger, and an adjustable needle guard to define the pre-set injection depth. It is intended to be used by a professional in a professional (e.g., clinical) setting. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00192896009240	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]