Power Dental USA

Basic Information

• Brand Name: Power Dental USA
• Primary DI: D9436967
• Version / Model: 6967
• Catalog Number: 6967
• Company Name: Power Dental U.S.A. Inc.
• Labeler DUNS: 081305064
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-06-20
• Public Version: 4
• Public Version Date: 2022-12-23
• Public Version Status: Update
• Public Device Record Key: f830cd74-d11d-4bb1-bf2f-a08df0c6c06a
• Distribution End Date: 2022-12-22

Device Description

MIRROR WITH MIRROR HANDLE #4 MIRROR C/S FRONT SURFACE WITH MIRROR HANDLE 6EZ C/S (6950+6911) FOR USE ONLY WITH POWER DUSA MIRRORS/HANDLES. WE DO NOT GUARANTEE FIT OF OTHER MANUFACTURERS MIRRORS/HANDLES

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: Yes
• 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
FTX	MIRROR, GENERAL & PLASTIC SURGERY	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31776	Dental mirror, reusable	A hand-held, dental instrument intended to be used by a dentist for intraoral inspection or inspection and retraction. It typically consists of a stainless steel shaft terminating at the distal end in a small round mirror that is angled to the shaft. This is a reusable device.	No	Active
64209	Tumour-therapy nanoparticle suspension, magnetic hyperthermia/thermoablation	An implantable nanomaterial designed to be locally administered into a tumour or tumour bed (e.g., brain tumour) and to be subsequently heated by an external alternating magnetic field whereby the heat released by the material is intended to destroy surrounding tumour cells (thermoablation), or alternatively sensitize tumour cells [hyperthermia] to enhance the efficacy of concomitant radiotherapy or chemotherapy. It is in the form of an aqueous suspension containing superparamagnetic iron oxide nanoparticles.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D9436967	HIBCC

Customer Contacts

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