Plasma Shield

Primary DI
27290019426022
Brand
Plasma Shield
Company
Plasmatica Ltd.
Model
1.0
Catalog number
PLA-04
Device description
Plasma Shield Disposable Part (PLA-AG000031). 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 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
Sterile
true
Single use
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
37290019426029PackageGS15In Commercial Distribution
47290019426026PackageGS15In Commercial Distribution
27290019426022PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3729001942602937290019426029
4729001942602647290019426026
2729001942602227290019426022

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope cold plasma antifogging support setA 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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
532350462
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
27290019426053Plasma ShieldPLA-04PLA-AG0000312025-12-15
27290019426008Plasma Shield1.0PLA-012023-05-17

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