Plasma Shield PLA-AG000031

GUDID 27290019426053

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, and a single-use, sterile trocar and scope cleaning set are supplied together with the Disposable Part

Plasmatica Ltd.

Endoscope cold plasma antifogging support set

• Primary Device ID: 27290019426053
• NIH Device Record Key: 0b03f609-5c87-451f-b122-5082506d7b44
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Plasma Shield
• Version Model Number: PLA-04
• Catalog Number: PLA-AG000031
• Company DUNS: 532350462
• Company Name: Plasmatica Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	27290019426053 [Primary]
GS1	47290019426057 [Package]; Package: Master box [25 Units]; In Commercial Distribution

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-23
• Device Publish Date: 2025-12-15

On-Brand Devices [Plasma Shield]

• 27290019426022: Plasma Shield Disposable Part. GMDN description: Endoscope cold plasma antifogging support set.
• 27290019426008: Plasma Shield Reusable Part. GMDN description: Endoscope cold plasma antifogging unit. The Plasm
• 27290019426053: Plasma Shield Disposable Part. GMDN description: Endoscope cold plasma antifogging support set.