Power Dental U.S.A., Inc.

Basic Information

• Brand Name: Power Dental U.S.A., Inc.
• Primary DI: D9435601L5601XL0
• Version / Model: 5601L/5601XL
• Catalog Number: 5601L/5601XL
• 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: 2021-07-17
• Public Version: 2
• Public Version Date: 2024-12-11
• Public Version Status: Update
• Public Device Record Key: 5d19b41c-6aca-4664-a484-db1b5d3ac112

Device Description

ORTHODONTIC DISTAL END CUTTER T/C SAFTY HOLD LONG HANDLE 15cm

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
HXZ	CUTTER, WIRE	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
33209	Orthodontic pliers	A hand-held manual dental instrument designed to hold small objects or to bend or to cut metal strips or wire used in orthodontic procedures. It is typically made of high-grade steel and consists of two arms/rods that form a handle proximally and extend distally through a pivot point to terminate with jaws available in various shapes depending on intended use. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D9435601L5601XL0	HIBCC

Customer Contacts

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