Duns Number:119193803
Device Description: HP Universal Mixing Tips fit 50ml high-performance round flange dual cartridges. 48 tips p HP Universal Mixing Tips fit 50ml high-performance round flange dual cartridges. 48 tips per bag in color-coded sizes. Specify 5.2mm (pink), owhen ordering.
Catalog Number
70-55315 PIN
Brand Name
HP Mixing Tips Pink
Version/Model Number
HP MIXER PINK 488G
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
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
EID
Product Code Name
Syringe, Restorative And Impression Material
Public Device Record Key
f1908350-8dbd-44bf-8286-861ff45c7078
Public Version Date
August 30, 2018
Public Version Number
1
DI Record Publish Date
July 30, 2018
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 | 93 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |