Duns Number:428755441
Device Description: Practical kit Monoart containing 8 different disposable products for 500 patients: 500 Tow Practical kit Monoart containing 8 different disposable products for 500 patients: 500 Towel Up, 500 saliva ejectors fix, 500 plastic cups, 250 tray papers, 200 Masks Pro.3, 160 Aprons PG30/80, 10 EM19 EVO, 2 bags Cotton rolls n.2.Colour: Yellow
Catalog Number
290222
Brand Name
Monoart
Version/Model Number
KIT MONOART® 8P 15,0 FIXED
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
8b2c875f-f9be-4520-9825-1b3412ca88c4
Public Version Date
May 06, 2020
Public Version Number
2
DI Record Publish Date
July 25, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |