Piezomed SA-320 1.8m

Basic Information

• Brand Name: Piezomed SA-320 1.8m
• Primary DI: J021300780001
• Version / Model: 30078000
• Company Name: W & H Dentalwerk Bürmoos GmbH
• Labeler DUNS: 300238441
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-19
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: a8f4ca2d-375c-4f89-81f4-caeb0189b8ec

Device Description

Piezoelectric ultrasonic device

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: 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
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

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	J021300780001	HIBCC

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 10 – 35 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 8 – 80 Percent (%) Relative Humidity
• Type: Handling Environment Humidity
• Temperature Range: 8 – 80 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -40 – 70 Degrees Celsius