Elevator

Basic Information

• Brand Name: Elevator
• Primary DI: B9745039630
• Version / Model: Dental Root Elevator
• Catalog Number: 503963
• Company Name: DR.FRIGZ INTERNATIONAL(PVT)LTD,
• Labeler DUNS: 645680125
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-21
• Public Version: 1
• Public Version Date: 2022-11-29
• Public Version Status: New
• Public Device Record Key: d799d21b-14a5-4e69-a78d-bdb02200d066

Device Description

Dental Root Elevator, Apical no.304

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: Yes

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EMJ	Elevator, Surgical, Dental	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63947	Periosteal elevator, single-use	A hand-held manual surgical instrument designed to lift/separate (elevate) or tunnel under the periosteum during surgery, typically orthopaedic, including use on the ribs. It may in addition be used in dentistry to access retained roots, or to remove them with surrounding bone. It is typically a one-piece instrument available in a variety of sizes and blade designs, including straight and curved blades, and often double-ended with a central handle; it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B9745039630	HIBCC