Duns Number:428755441
Device Description: Roll of 100 patients aprons made from a waterproof polyethylene layer. The perforated tear Roll of 100 patients aprons made from a waterproof polyethylene layer. The perforated tear-off parts make the aprons easy to use. The system with laces, allows to tie apron directly to the patient’s neck. Available in two sizes (120 and 160 cm respectively), these protect patients down to the knee or ankles. Carton of 6 rolls. Dimensions: 160 x 53 cm. Colour: blue.
Catalog Number
21910153
Brand Name
Monoart
Version/Model Number
MONOART® APRON PG 20 XLong
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
9c3bdbf6-0203-4aad-833e-6dadb90173be
Public Version Date
June 26, 2020
Public Version Number
1
DI Record Publish Date
June 18, 2020
Package DI Number
E307219101531
Quantity per Package
100
Contains DI Package
E307219101530
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Aprons
| 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 |