Duns Number:872967679
Device Description: A sterile component of a wound therapy ultrasound system intended to be attached to the sy A sterile component of a wound therapy ultrasound system intended to be attached to the system treatment wand to interface low frequency ultrasound energy from the treatment wand with a fluid solution (e.g., saline) for the production of an ultrasound-conductive mist used to promote wound healing. it typically includes fluid delivery tubing and is intended to fit on the distal end of the treatment wand. This is a single-use device.
Catalog Number
CP-80024
Brand Name
MIST 360 Applicator
Version/Model Number
CP-80024
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K122246,K122246,K122246
Product Code
NRB
Product Code Name
Wound Cleaner, Ultrasound
Public Device Record Key
6fb43518-26d6-45b3-a50b-72ab8eec94ce
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 07, 2016
Package DI Number
20816789010246
Quantity per Package
12
Contains DI Package
10816789010249
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Corrugated carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |