Duns Number:428755441
Device Description: Monoart Istant Ice guaratees better quality and longer lasting cooling. Disposable bag ma Monoart Istant Ice guaratees better quality and longer lasting cooling. Disposable bag made of K2P-cellulosa. Shelf life: 5 years. Size 150x175 mm. Carton of 24 bags.
Catalog Number
23230020
Brand Name
Monoart
Version/Model Number
MONOART INSTANT ICE
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
IMD
Product Code Name
Pack, Hot Or Cold, Disposable
Public Device Record Key
126eaf5a-192c-43b6-939e-d0ed8a42c0db
Public Version Date
August 05, 2019
Public Version Number
1
DI Record Publish Date
July 26, 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 |