Plasma Shield

Primary DI
27290019426008
Brand
Plasma Shield
Company
Plasmatica Ltd.
Model
1.0
Catalog number
PLA-01
Device description
Plasma Shield Reusable Part (PLA-AG000146). 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 foldedsurgical drape and packaged in a pouch. A single-use, sterile anti-fog solution and foam is supplied together with the Disposable Part.
Published
2023-05-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery
OCTAnti Fog Solution And Accessories, Endoscopy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2
OCTAnti Fog Solution And Accessories, EndoscopyGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290019426001Direct MarkingGS10
47290019426002PackageGS16In Commercial Distribution
27290019426008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1729001942600117290019426001
4729001942600247290019426002
2729001942600827290019426008

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope cold plasma antifogging unitAn 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1 (800) 280-2183info@plasmatica.com

Regulatory Flags#

DUNS number
532350462
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
27290019426053Plasma ShieldPLA-04PLA-AG0000312025-12-15
27290019426022Plasma Shield1.0PLA-042023-05-17

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