RECIPROCATING MICROSAW

Basic Information

• Brand Name: RECIPROCATING MICROSAW
• Primary DI: J00716010980011
• Version / Model: 1601098-001
• Catalog Number: 1601098-001
• Company Name: Bien-Air Dental SA
• Labeler DUNS: 480082080
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-01-29
• Public Version: 1
• Public Version Date: 2021-02-08
• Public Version Status: New
• Public Device Record Key: 6790e801-b639-4d71-9344-94daed757223

Device Description

The reciprocating microsaw handpiece is intended to be used in oral and maxillofacial surgery for cutting bone and hard tissues.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• 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
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	878.4820	1

GMDN Terms

Code	Name	Definition	Implantable	Status
52749	Surgical power tool system handpiece, sawing, line-powered	A hand-held, line-powered device (which may in addition include a rechargeable battery) that consists of a motorized saw handpiece intended to provide sagittal, oscillating, or reciprocating movement for attachable serrated blades designed to cut through hard/tough tissue during surgery. The device may be of the micro or macro design. It is powered from a control unit that supplies mains, stepped-down, low-voltage electricity (e.g., 24 volt) directly via an electrical connection cable. It is typically operated with a hand- or foot-switch. This is a reusable device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	J00716010980011	HIBCC

Customer Contacts

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