Duns Number:428755441
Device Description: Disposable, flexible saliva ejectors made of non-toxic, transparent PVC. Removable rounded Disposable, flexible saliva ejectors made of non-toxic, transparent PVC. Removable rounded tips. Integrated metal wire. Diameter 6,5 mm. Bag of 100 pcs. Box of 5.000 pcs. Color: transparent.
Catalog Number
22810148
Brand Name
Monoart
Version/Model Number
MONOART® EM15 SALIVA EJECTOR
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
DYN
Product Code Name
Mouthpiece, Saliva Ejector
Public Device Record Key
58f1d682-b061-4475-a158-679beba8322f
Public Version Date
December 10, 2019
Public Version Number
1
DI Record Publish Date
December 02, 2019
Package DI Number
E307228101481
Quantity per Package
100
Contains DI Package
E307228101480
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BAG
| 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 |