Duns Number:428755441
Device Description: Universal moulded tip for surgical aspirator. It can be sterilised in autoclave at 134°C. Universal moulded tip for surgical aspirator. It can be sterilised in autoclave at 134°C. Medical Device Class Ila. Connection diameter: 11mm. Lenght: 200mm. Box of 10 pcs. Color: light grey
Catalog Number
22910110
Brand Name
Monoart
Version/Model Number
MONOART EM40
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
GEA
Product Code Name
Cannula, Surgical, General & Plastic Surgery
Public Device Record Key
620f21b4-2381-45f8-8ade-91229cff4fcc
Public Version Date
December 17, 2019
Public Version Number
1
DI Record Publish Date
December 09, 2019
Package DI Number
E307229101101
Quantity per Package
10
Contains DI Package
E30722910110
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 |