SonaStar

Basic Information

• Brand Name: SonaStar
• Primary DI: 00841626100565
• Version / Model: CFSM5-T101
• Company Name: MISONIX, INC.
• Labeler DUNS: 065963449
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 4
• Public Version Date: 2022-07-04
• Public Version Status: Update
• Public Device Record Key: 6a1c649b-1502-49f7-9c1b-fdac70a83cdc

Device Description

SonaStar Suction Tubing, 1 Meter

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	878.4400	2
LFL	Instrument, Ultrasonic Surgical	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
42834	Vacuum hose	A length of reinforced colour-coded flexible tubing intended to be connected to a vacuum-producing medical device, medical equipment, or a medical system to channel incoming suction. It has a thick wall to prevent collapse due to the negative pressure of the vacuum and typically produced according to ISO5359. It is available in various lengths, including standard coil lengths. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841626100565	GS1

Premarket Submissions

Submission Number	Supplement Number
K062471	000