Power Dental USA

Basic Information

• Brand Name: Power Dental USA
• Primary DI: D9436710E0
• Version / Model: 6710E
• Catalog Number: 6710E
• Company Name: Power Dental U.S.A. Inc.
• Labeler DUNS: 081305064
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-13
• Public Version: 4
• Public Version Date: 2023-05-12
• Public Version Status: Update
• Public Device Record Key: 9ccbf437-868b-4f6a-be72-0a5240c89085

Device Description

SURGICAL SUCTION 6mm PREMIUM BLACK EDITION

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• 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

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JOL	CATHETER AND TIP, SUCTION	General Hospital	880.6740	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38749	Surgical/emergency suction cannula, non-illuminating, reusable	An atraumatic, invasive, hand-operated, single-lumen, rigid/semi-rigid tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or to clear an airway obstruction. It is not dedicated to dental, intrauterine, or liposuction procedures, and is neither an ophthalmic nor an intravascular device; it is not designed for surgical irrigation. Sometimes referred to as a suction tube or tip, it may incorporate a handle with side valve(s)/hole(s), and may be provided with a stylet, sheath, and/or connection tubing; it does not include a light source or fibreoptic bundle. This is a reusable device.	No	Active
34859	Dental suction system	An assembly of devices designed to aspirate water, blood, saliva, and tooth debris from the oral cavity by means of suction, to maintain a clear operative site during dental surgical, professional hygiene, and orthodontic procedures. It consists of an electrically-powered suction pump with a control knob and patient contact devices (typically suction handpiece/tip); collection containers, spittoon, tubing, and amalgam separator are also often included.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D9436710E0	HIBCC

Customer Contacts

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