Duns Number:687789453
Device Description: This device connected with manually-operated syringe only is used in order to spray oral c This device connected with manually-operated syringe only is used in order to spray oral cavity with cleansing fluid.
Catalog Number
951-205
Brand Name
Irrigation Tip
Version/Model Number
END OPEN TYPE 25G
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JEW
Product Code Name
Tip, Rubber, Oral Hygiene
Public Device Record Key
46ee1c7d-1f5e-40d1-be7c-880a47013402
Public Version Date
September 02, 2020
Public Version Number
1
DI Record Publish Date
August 25, 2020
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 | 4806 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 158 |