Duns Number:428755441
Device Description: Cotton rolls Monoart No. 3 diameter 12 mm, length 37 mm. Bag of 300 gr.
Catalog Number
22610103
Brand Name
Monoart
Version/Model Number
MONOART® COTTON ROLLS
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
EFN
Product Code Name
Cotton, Roll
Public Device Record Key
99d5f737-bdc3-4a38-9e41-4593e0d1bfa5
Public Version Date
December 25, 2019
Public Version Number
1
DI Record Publish Date
December 17, 2019
Package DI Number
E307226101031
Quantity per Package
30
Contains DI Package
E307226101030
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| 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 |