Wound Cleaner, Ultrasound

Product Code: NRB

General & Plastic Surgery Ultrasonic Medical Devices (Miscellaneous)

Definition: The Ultrasound Wound Cleaner/mild Debridement System Is A Device That Delivers A Cleaning Fluid To The Wound That Is Pulsed Using Low Power Ultrasound Radiation. The Device Is Intended To Clean And Mildly Debride Wounds. The Ultrasound Generator Must Deliver 1. 0 Mw/cm2 Or Less Energy To The Wound.

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 878.4410


Radiation TypeAcoustic
Radition SafetyNone
Annual ReportsNo

Products Classified as NRB

5780Wound Cleaner, UltrasoundLow Energy Ultrasound Wound Cleaner.

Total Product Life Cycle (TPLC) Devices

5780Wound Cleaner, UltrasoundLow Energy Ultrasound Wound Cleaner.

FDA Consensus Standards

Wound Cleaner, Ultrasound [32412]21 CFR §878.4410 🔎

Pre-market Notifications for NRB

K162721Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel ApplicatorALLIQUA BIOMEDICAL, INC.
K140782ULTRAMIST SYSTEM, ULTRAMIST GENERATOR, ULTRAMIST TREATMENT WAND, ULTRAMIST APPLICATORCELLERATION, INC.
K131096AR1000 SERIES ULTRASONIC WOUND THERAPY SYSTEMAROBELLA MEDICAL, LLC
K123980SONICONE PLUS ULTRASOUND WOUND CARE SYSTEM AND ACCESSORIESMISONIX, INC.
K122246MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12CELLERATION, INC.
K112782MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIESMISONIX, INC.
K091038AS 1000 ULTRASOUND WOUND THERAPY SYSTEMAROBELLA MEDICAL, LLC
K050129CELLERATION MIST THERAPY SYSTEM 5.1CELLERATION, INC.

Global Unique Device Identification Database

20816789010253Wound Cleaner, Ultrasound
20816789010246Wound Cleaner, Ultrasound
20816789010239Wound Cleaner, Ultrasound
00816789010211Wound Cleaner, Ultrasound
10816789010201Wound Cleaner, Ultrasound
00853077002244Wound Cleaner, Ultrasound
00853077002237Wound Cleaner, Ultrasound
00853077002220Wound Cleaner, Ultrasound
00853077002213Wound Cleaner, Ultrasound
10853077002203Wound Cleaner, Ultrasound
00853077002176Wound Cleaner, Ultrasound
00853077002169Wound Cleaner, Ultrasound
00853077002152Wound Cleaner, Ultrasound
00853077002145Wound Cleaner, Ultrasound
00853077002138Wound Cleaner, Ultrasound

Maude Adverse Events

MIST THERAPY SYSTEMCELLERATION, INC.2010-10-22
MIST THERAPY SYSTEMCELLERATION, INC.2009-04-21
MIST THERAPY SYSTEMCELLERATION, INC.2009-02-04
MIST THERAPY SYSTEMCELLERATION, INC.2008-12-30
MIST THERAPY SYSTEMCELLERATION, INC.2008-12-12
MIST THERAPY SYSTEMCELLERATION, INC.2008-07-17
MIST THERAPY SYSTEMCELLERATION, INC.2008-04-15
MIST THERAPY SYSTEMCELLERATION, INC.2008-01-25
MIST THERAPY SYSTEMCELLERATION, INC.2007-09-21
MIST THERAPY SYSTEMCELLERATION, INC.2007-06-07
MIST THERAPY SYSTEM 5.0CELLERATION, INC.2007-06-07
MIST THERAPY SYSTEMCELLERATION, INC.2006-07-17
MIST THERAPY SYSTEMCELLERATION, INC.2006-06-16
MIST THERAPY SYSTEMCELLERATION, INC.2006-06-16
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