Power Dental USA

Basic Information

• Brand Name: Power Dental USA
• Primary DI: D9436920S00
• Version / Model: 6920S
• Catalog Number: 6920S
• 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: 3
• Public Version Date: 2022-03-24
• Public Version Status: Update
• Public Device Record Key: 77ffd5db-c658-4819-a98f-73e888d67a8f

Device Description

PALATAL HARVESTING KIT SPECIAL OFFSET DESIGN HOLD 2 BLADES SET OF 3

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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
GDZ	HANDLE, SCALPEL	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
12235	Scalpel handle, reusable	A device that is an interchangeable component of a scalpel and that functions as a handle designed to mount a compatible blade. This device with the blade become a single-bladed surgical instrument intended to be used by a physician for cutting or dissecting tissue. The device is typically made of metal (e.g., stainless steel or brass). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D9436920S00	HIBCC

Customer Contacts

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