MECTRON

Basic Information

• Brand Name: MECTRON
• Primary DI: E322051700030020
• Version / Model: PIEZOSURGERY PLUS - US
• Catalog Number: 05170003-002
• Company Name: MECTRON SPA
• Labeler DUNS: 436664734
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-30
• Public Version: 4
• Public Version Date: 2018-07-24
• Public Version Status: Update
• Public Device Record Key: 922e2d41-cd26-45d5-a9a6-d9b139811011

Device Description

The Piezosurgery® Plus is an ultrasonic surgical system consisting of handpieces and associated tips for osteotomy, osteoplasty and drilling in a variety of surgical procedures, including but not limited to: - Otolaryngology - Oral/maxillofacial - Hand and foot - Neurosurgery - Spine - Plastic/reconstructive, and - Orthopedic surgery The device may also be used with endoscopic visual assistance to perform the above listed procedures.

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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	878.4820	1
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	882.4310	2
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	874.4250	2
JDX	Instrument, Surgical, Sonic And Accessory/Attachment	Orthopedic	888.4580	2
DZI	Drill, Bone, Powered	Dental	872.4120	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47010	Dental ultrasonic surgical system	An assembly of devices that converts high frequency current into ultrasonic oscillation to mechanically fragment and cut bone upon contact with a vibrating tip during dental surgery, typically in combination with irrigation. It typically includes an energy-producing generator with monitoring functions, a handpiece(s) with tip(s) to convert and apply the energy, connecting cables, and a foot-switch to regulate the energy. It is used for implant-site preparation, dental extraction, distraction, sinus lift, periodontal surgery, cyst removal, extraction of bone block, bone harvesting, osteoplasty and osteotomy.	No	Active
45981	Hard-tissue ultrasonic surgical system	An assembly of devices designed to use ultrasonic energy to mechanically fragment and cut bone and/or bone cement [e.g., acrylic, polymethylmethacrylate (PMMA)] upon contact during an orthopaedic surgical procedure (e.g., arthroplasty revision, spinal surgery); some types may in addition be intended for dental/craniomaxillofacial applications (e.g., reconstructive/plastic surgery) however none are dedicated exclusively to dental applications. It typically includes an ultrasonic energy-producing generator, a handpiece with cutting tip(s)/probe(s) to apply the energy and remove (aspirate) material, and connecting cables.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	E322051700030020	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K153743	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -10 – 70 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal
• Type: Handling Environment Temperature
• Temperature Range: 10 – 30 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 30 – 75 Percent (%) Relative Humidity
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 80 – 106 KiloPascal