Power Dental U.S.A., Inc.

Basic Information

• Brand Name: Power Dental U.S.A., Inc.
• Primary DI: D943N7814C00
• Version / Model: N7814C
• Catalog Number: N7814C
• 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: 2021-07-13
• Public Version: 4
• Public Version Date: 2023-06-02
• Public Version Status: Update
• Public Device Record Key: e1b6ae11-cf8d-4256-a5e7-e77214f47e1f
• Distribution End Date: 2022-06-17

Device Description

POWER EASY BONE EXPANDER KIT

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
HWD	STARTER, BONE SCREW	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62546	Intraoperative orthopaedic bone pin/screw, single-use	A small rod intended to be inserted into bone to temporarily anchor a surgical instrument (e.g., retractor, implant aligner) and/or implantable device (e.g., fixation plate) to the bone during an orthopaedic surgical procedure; it is not left in situ after the procedure. It may be wholly- or partially-threaded for screwing into bone, and may have other physical features to enable fixation of surgical instruments/devices. It is made of metallic (e.g., stainless steel) or polymer (radiolucent) material and is available in various shapes and sizes. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D943N7814C00	HIBCC

Customer Contacts

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