swiftPro URT Applicator Tip

Basic Information

• Brand Name: swiftPro URT Applicator Tip
• Primary DI: 05060652910091
• Version / Model: SWF-AT02
• Catalog Number: SWF-AT02
• Company Name: EMBLATION LIMITED
• Labeler DUNS: 211334261
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-12-04
• Public Version: 1
• Public Version Date: 2023-12-12
• Public Version Status: New
• Public Device Record Key: 81d662dc-b38d-45fb-83a7-52f763f1e8ec

Device Description

The swiftPro URT applicator tip is provided as a single-use, non-sterile disposable tip, which is connected to the Swift® handpiece.

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NEY	System, Ablation, Microwave And Accessories	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65056	Intraoperative gamma radiation detection system probe cover	A polymer sheath designed to cover an intraoperative gamma radiation detection system probe (not included) to create a physical barrier between the patient and the probe. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060652910091	GS1

Premarket Submissions

Submission Number	Supplement Number
K222388	000