Duns Number:113170088
Device Description: 19 Gauge Tips for use with compatible syringes.
Catalog Number
19TIPS10
Brand Name
Tips
Version/Model Number
19TIPS10
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ECP
Product Code Name
Instrument, Ligature Tucking, Orthodontic
Public Device Record Key
10853b48-2449-49eb-a63d-b5c70af3669c
Public Version Date
July 24, 2020
Public Version Number
7
DI Record Publish Date
September 12, 2016
Package DI Number
D79819TIPS102
Quantity per Package
50
Contains DI Package
D79819TIPS101
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 73 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 279 |