dermaPACE System (Console with applicator)

Basic Information

• Brand Name: dermaPACE System (Console with applicator)
• Primary DI: 00812265010225
• Version / Model: DEP0330/DAP0332
• 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: 2
• Public Version Date: 2021-07-08
• Public Version Status: Update
• Public Device Record Key: 42a4ff12-ddba-4207-95d6-05cec4725be2

Device Description

The dermaPACE console and applicator shipped together. An assembly of devices designed to provide high-energy, spark-gap generated (electrohydraulic) extracorporeal shock wave intended to treat diabetic foot ulers.

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: No
• 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
PZL	Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers	General, Plastic Surgery	878.4685	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59043	Dermatological extracorporeal shock wave therapy system	An assembly of devices designed to provide spark-gap-generated extracorporeal shock wave therapy (ESWT) intended to treat acute and chronic conditions of the skin and subcutaneous soft tissues (e.g., arterial, venous, diabetic or pressure ulcers; burns; postoperative or traumatic wounds; cellulite). It typically consists of a generator that supplies the high voltage energy; and a hand-held, fluid-filled, shock wave applicator that produces spark-gap (electrohydraulic) energy delivered non-invasively to the area of the skin in contact with the applicator. Treatment parameters are intended to be input manually or from a pre-programmed radio-frequency identification (RFID) card.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00812265010225	GS1

Customer Contacts

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