Profile Applicator

Basic Information

• Brand Name: Profile Applicator
• Primary DI: 00812265010300
• Version / Model: FLE0104
• Company Name: Sanuwave, Inc.
• Labeler DUNS: 832217439
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-01-25
• Public Version: 1
• Public Version Date: 2021-02-02
• Public Version Status: New
• Public Device Record Key: bfc7db0f-4379-4cae-b9e0-e67d1ac00285

Device Description

Profile Hand-held Treatment Applicator designed to use with Profile Control Console (PRF100)

Device Characteristics

• Single Use: No
• 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: 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
ISA	Massager, Therapeutic, Electric	Physical Medicine	890.5660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
59045	Dermatological extracorporeal shock wave therapy system applicator	A hand-held component of a dermatological extracorporeal shock wave therapy (ESWT) system designed to transmit spark-gap-generated (electrohydraulic) shock waves to treat acute and chronic conditions of the skin and subcutaneous soft tissues (e.g., arterial, venous, diabetic or pressure ulcers; burns; traumatic wounds; cellulite). It is connected to the system generator by a flexible conduit and has a fluid-filled head portion intended to be moved over the skin surface of the treatment area for application of the shock waves. It is typically used with a sterile drape during treatment of open wounds and requires a sterile transmission media (ultrasonic gel). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00812265010300	GS1

Customer Contacts

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