Duns Number:009900424
Device Description: Mixing Tip for 10ml Cartridge with Brown Base & Clear Mixer (Pkg. of 30 pcs.)
Catalog Number
S521
Brand Name
Parkell®
Version/Model Number
S521
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 09, 2020
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)
Yes
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
5e6571c3-2934-40f7-8020-b97b6e67dd9a
Public Version Date
June 08, 2021
Public Version Number
2
DI Record Publish Date
August 16, 2019
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 | 36 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 476 |
| U | Unclassified | 19 |