Duns Number:276075371
Device Description: Endodontic instrument for professionnal dental use only
Catalog Number
20121002
Brand Name
PASTINJECT
Version/Model Number
n15 L21 ISO M07
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
EIY
Product Code Name
Instrument, Filling, Plastic, Dental
Public Device Record Key
525623e0-b216-4fac-ba7d-4f2b0deca595
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
July 23, 2020
Package DI Number
J015201210022
Quantity per Package
10
Contains DI Package
J015201210021
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Grouping box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 64 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |