Sonopet iQ

Basic Information

• Brand Name: Sonopet iQ
• Primary DI: 07613327298611
• Version / Model: 5500255000
• Catalog Number: 5500-255-000
• Company Name: STRYKER CORPORATION
• Labeler DUNS: 196548481
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-04-23
• Public Version: 2
• Public Version Date: 2019-05-07
• Public Version Status: Update
• Public Device Record Key: 611ebbc8-4414-4ee2-bdc2-f43b4abfc6f9

Device Description

Universal Angled Handpiece

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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LFL	Instrument, ultrasonic surgical	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
63967	Hard/soft-tissue ultrasonic surgical system handpiece	A hand-held component of an ultrasonic surgical system intended to convert high frequency electrical current into an ultrasonic oscillation, and transfer the energy to an attachable tip, to mechanically fragment and cut both bone and soft-tissue cells upon contact (depending on the type of tip attached) during multiple types of surgery: it is not dedicated exclusively to dental applications. It typically includes cables for power supply and tubing to circulate cooling fluid to the attachable tip. 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	07613327298611	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 40 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 10 – 85 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 10 – 27 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 75 Percent (%) Relative Humidity
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal