Duns Number:428755441
Device Description: Universal tips for surgical aspirators, recommended for procedures on adults. Ergonomic, n Universal tips for surgical aspirators, recommended for procedures on adults. Ergonomic, non-slip grips and linear shape to keeps them quiet and promotes better hygiene and cleaning. They can be sterilizedin autoclaves at up to 134°C. Connection diameter:16 mm. Length: 129 mm. Box of 10 pieces of the same colour.Colour: grey.
Catalog Number
22931001
Brand Name
Monoart
Version/Model Number
MONOART EM21
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
0c3d1e28-503b-4a75-9800-a5f48f53383d
Public Version Date
December 16, 2019
Public Version Number
1
DI Record Publish Date
December 06, 2019
Package DI Number
E307229310011
Quantity per Package
10
Contains DI Package
E307229310010
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 |