Carbon Wave Patch

Basic Information

• Brand Name: Carbon Wave Patch
• Primary DI: 00865601000329
• Version / Model: CWP
• Company Name: FOCUS MEDICAL, LLC
• Labeler DUNS: 841432912
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-16
• Public Version: 1
• Public Version Date: 2022-09-26
• Public Version Status: New
• Public Device Record Key: b28039cd-383d-47b9-ab14-76e05407677d

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• Has Lot/Batch Number: Yes
• 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
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	878.4022	1

GMDN Terms

Code	Name	Definition	Implantable	Status
66441	Dermatological lasing acoustic wave patch	A hydrogel skin patch intended to be used during dermatological laser pulsed therapy (also known as Q-switching) to interface between the laser energy applicator and the patient’s skin to facilitate production of therapeutic acoustic shock waves upon application of laser energy pulses. It is typically used to disrupt subdermal cellulite-tethering septal fibrous tissue for skin-contouring to minimize the manifestation of cellulite. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00865601000329	GS1