Plasmage

Basic Information

• Brand Name: Plasmage
• Primary DI: 00860008655806
• Version / Model: 1
• Company Name: Brera Medical Inc
• Labeler DUNS: 032587824
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-14
• Public Version: 2
• Public Version Date: 2023-04-04
• Public Version Status: Update
• Public Device Record Key: d9364425-e2ed-46ea-9aab-3788dd62e97a

Device Description

Electrosurgical device for soft tissue coagulation

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44776	Electrosurgical system	An assembly of devices intended to generate, and apply radio-frequency (RF) alternating current to soft tissues for cutting and coagulation during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues (i.e., not a radio-frequency ablation system). The assembly includes a mains electricity-powered (AC-powered) RF generator with monitoring functions/controls, connection cables, a handpiece, and electrodes to apply the energy to the surgical site. Tissue resistance to the electrical current creates the heat as the current travels through the body between electrodes; it is not intended for inert gas-enhanced electrosurgery.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860008655806	GS1

Premarket Submissions

Submission Number	Supplement Number
K202106	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 15 – 40 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: -20 – 50 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: – 75 Percent (%) Relative Humidity
• Type: Storage Environment Humidity
• Temperature Range: – 90 Percent (%) Relative Humidity