Duns Number:688322841
Device Description: Gutta Percha Points and Bars 02 taper #25, 120 Points, P71
Catalog Number
-
Brand Name
Gutta Percha 02-25
Version/Model Number
0408
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EKM
Product Code Name
Gutta-Percha
Public Device Record Key
3b5d0eda-5e72-48c8-94a2-e529bc0dba9a
Public Version Date
June 07, 2021
Public Version Number
1
DI Record Publish Date
May 28, 2021
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 | 1335 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 284 |