Plasma Shield

Basic Information

• Brand Name: Plasma Shield
• Primary DI: 27290019426008
• Version / Model: 1.0
• Catalog Number: PLA-AG000146
• Company Name: Plasmatica Ltd.
• Labeler DUNS: 532350462
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-05-17
• Public Version: 1
• Public Version Date: 2023-05-25
• Public Version Status: New
• Public Device Record Key: a9143051-823f-46e9-9128-cf1bf357fe37

Device Description

Plasma Shield Reusable Part. GMDN description: Endoscope cold plasma antifogging unit. The Plasma Shield is intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope lens. The Plasma Shield device is designed for reducing laparoscopic lens fogging by performing cold plasma treatment of a laparoscope lens. The Plasma Shield device is a cold plasma-based device to be used in an operating room, prior to and during laparoscopic procedures. The cold plasma creates a super hydrophilic scope lens surface after treatment (aka activation). The device does not interact directly with the patient’s body. The Plasma Shield consists of these components and accessories: - The main system is a Reusable Part (RP) that generates the cold plasma required to treat the scope for defogging. - A Disposable Part (DP) – a single-use, sterilized component interfacing with the scope itself and used for each procedure (can be used multiple times within the same procedure for the same patient). The DP assembly includes a folded surgical drape and packaged in a pouch. A single-use, sterile anti-fog solution and foam is supplied together with the Disposable Part.

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	876.1500	2
OCT	Anti Fog Solution And Accessories, Endoscopy	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66670	Endoscope cold plasma antifogging unit	An electrically-powered unit designed to prevent the occurrence of condensed vapour (fog) on an endoscope lens by creating a hydrophilic lens surface, using cold plasma energy, prior to a procedure. It is a tabletop unit with controls and a port designed to accept the endoscope lens, whereby cold plasma is generated using high-voltage radio-frequency current.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	27290019426008	GS1
Direct Marking	17290019426001	GS1

Customer Contacts

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