NA

Basic Information

• Brand Name: NA
• Primary DI: 04250321512652
• Version / Model: 612K0039-50
• Company Name: Söring GmbH
• Labeler DUNS: 322238346
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2016-09-17
• Public Version: 4
• Public Version Date: 2021-11-09
• Public Version Status: Update
• Public Device Record Key: 3aa30bee-82f5-4470-99d4-bb84877ae9de
• Distribution End Date: 2020-01-01

Device Description

Flue, for 92-112

Device Characteristics

• Single Use: Yes
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BTA	Pump, Portable, Aspiration (Manual Or Powered)	General, Plastic Surgery	878.4780	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45184	Ultrasonic surgical system flue	A sterile device used to encompass the distal end of a dedicated ultrasonic surgical system handpiece and tip to provide a pathway for the delivery of irrigation fluid. The device helps to concentrate the fluid at the tip of the handpiece, remove some of the heat generated during surgery, eliminate misting that can impair visibility of the surgical site, and reduce the amount of irrigant needed. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04250321512652	GS1
Unit of Use	04250321512638	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K992026	000