Duns Number:428755441
Device Description: Roll of 60 patient aprons made of 1 ply paper + 1 ply of waterproof polyethylene. Size 810 Roll of 60 patient aprons made of 1 ply paper + 1 ply of waterproof polyethylene. Size 810 x 530 mm. Carton of 6 rolls. Colour: yellow
Catalog Number
22010313
Brand Name
Monoart
Version/Model Number
MONOART APRON PG30
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
dbfebbda-bad2-4fdf-9178-fc66a91773e0
Public Version Date
December 24, 2019
Public Version Number
1
DI Record Publish Date
December 16, 2019
Package DI Number
E307220103131
Quantity per Package
6
Contains DI Package
E307220103132
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 |