Plasma Shield

Basic Information

• Brand Name: Plasma Shield
• Primary DI: 27290019426022
• Version / Model: 1.0
• Catalog Number: PLA-AG000031
• 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: 6e24091d-329a-4cf9-94c0-03f45b28b81b

Device Description

Plasma Shield Disposable Part. GMDN description: Endoscope cold plasma antifogging support set. 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: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
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
66668	Endoscope cold plasma antifogging support set	A collection of devices intended to be used during cold plasma antifog activation of an endoscope by providing: 1) a physical barrier between an endoscope cold plasma antifogging unit and the endoscope/sterile field; and 2) an antifog solution to complement cold plasma treatment. It includes a plastic drape with a dedicated plug-in component intended to shield the internal portion of the antifogging unit, and an antifog solution typically with an application sponge. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	27290019426022	GS1
Package	37290019426029	GS1	Box	5	In Commercial Distribution

Customer Contacts

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