Plasma Shield
Basic Information
- Brand Name
- Plasma Shield
- Primary DI
- 27290019426053
- Version / Model
- PLA-04
- 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
- 2025-12-15
- Public Version
- 1
- Public Version Date
- 2025-12-23
- Public Version Status
- New
- Public Device Record Key
- 0b03f609-5c87-451f-b122-5082506d7b44
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, and a single-use, sterile trocar and scope cleaning set are supplied together with the Disposable Part
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 |
|---|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | 876.1500 | 2 |
| OCT | Anti Fog Solution And Accessories, Endoscopy | Gastroenterology, Urology | 876.1500 | 2 |
| MNL | Accessories, Cleaning Brushes, For Endoscope | Gastroenterology, Urology | 876.1500 | 1 |
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 | 27290019426053 | GS1 | ||||
| Package | 47290019426057 | GS1 | Master box | 25 | In Commercial Distribution |