NA

Basic Information

• Brand Name: NA
• Primary DI: 04250321529834
• Version / Model: 700S0310
• Company Name: Söring GmbH
• Labeler DUNS: 322238346
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 12
• Record Status: Published
• Publish Date: 2016-09-17
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 72793678-b659-42ef-a50a-959a3fef8907

Device Description

Irrigation tubing, double packed, 5m

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
45185	Ultrasonic surgical system tubing set	A sterile collection of dual-lumen tubing and connectors that are used in an ultrasonic surgical system to transport irrigation fluid through one lumen to the surgical site, and remove the aspirate through the other for collection in a suction bottle/canister. The tubing connects to the system's generator at one end and will typically be fitted with safety connectors; it is used only with systems that include irrigation/aspiration. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04250321529834	GS1
Unit of Use	04250321583454	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K992026	000