NEVESKIN

Basic Information

• Brand Name: NEVESKIN
• Primary DI: 08056590170540
• Version / Model: NEVESKIN
• Company Name: ELETTRONICA PAGANI SRL
• Labeler DUNS: 430315948
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-04-26
• Public Version: 1
• Public Version Date: 2022-05-04
• Public Version Status: New
• Public Device Record Key: d900f84a-c974-4310-a7ac-9e482eac61b4

Device Description

Cold and hot generator for skin cooling and heating in minor pain and skin imperfections.

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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	890.5700	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61186	Multi-modality physical therapy system	An assembly of electrically-powered devices designed to apply multiple different energies (e.g., light-energy, ultrasound, radio-frequency electrical stimulation, and microcurrent electrotherapy) either alone or in sequence, but not simultaneously, to noninvasively treat/prevent a variety of soft-tissue, neuromuscular, and musculoskeletal injuries/disorders (e.g., joint pain/inflammation, stiffness, soft tissue injuries, muscle atrophy, plantar fasciitis); it may in addition be used for aesthetic skin/body contouring (e.g., minimize cellulite, loose or wrinkled skin). It consists of a multi-modality control unit/generator, and dedicated applicators for the transcutaneous delivery of energy.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08056590170540	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]