Duns Number:428755441
Device Description: Disposable towels made of pure cellulose, highly absorbent, innovative packaging with open Disposable towels made of pure cellulose, highly absorbent, innovative packaging with open/close system. They come in the original floral pattern, available in four bright colours, to give a unique look to every dental practice. Dimensions: 330x450 mm. Carton of 500 pieces.Colour: floral lilac
Catalog Number
21810495
Brand Name
Monoart
Version/Model Number
MONOART® TOWEL UP
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KHR
Product Code Name
Absorber, Saliva, Paper
Public Device Record Key
731627fb-e7ab-4883-bc43-64491b798590
Public Version Date
December 25, 2019
Public Version Number
1
DI Record Publish Date
December 17, 2019
Package DI Number
E307218104951
Quantity per Package
500
Contains DI Package
E307218104950
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 126 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 12 |