Duns Number:012430880
Device Description: HP Mixing Tip Yellow Small 4.2mm
Catalog Number
9000764
Brand Name
Henry Schein
Version/Model Number
9000764
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
04e4e245-fb3b-4a56-86c8-7622e2bf0c11
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
March 30, 2017
Package DI Number
20304040051850
Quantity per Package
50
Contains DI Package
10304040051853
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 | 3829 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2579 |
| 3 | A medical device with high risk that requires premarket approval | 1 |
| U | Unclassified | 34 |