Power Dental USA

Basic Information

• Brand Name: Power Dental USA
• Primary DI: D9434033B00
• Version / Model: 1300
• Catalog Number: 1300
• 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: 3
• Public Version Date: 2022-06-17
• Public Version Status: Update
• Public Device Record Key: d5137ec5-b6a6-4082-a33e-30c84576b3b5
• Distribution End Date: 2022-06-16

Device Description

ASDF

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
EID	SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43999	Bone graft syringe, single-use	A calibrated barrel (cylinder) with plunger intended to be used to aspirate bone graft materials (e.g., autologous blood or bone marrow with allograft, autograft, demineralized bone, or synthetic/composite bone matrix graft materials) and deliver them to a surgical site during an orthopaedic, oral, or maxillofacial surgical procedure. This is a single-use device.	No	Active
11791	Dressing/utility forceps, scissors-like, reusable	A hand-held manual instrument designed primarily for non-dedicated grasping of devices, sponges and/or dressings during a procedure; it is neither intended for tissue manipulation nor endoscopic use. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D9434033B00	HIBCC

Customer Contacts

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