Duns Number:343831731
Device Description: EndoPilot Obtura expansion set consist of:1x BackFill Gun Obtura, 1x Obtura Needle Lock Nu EndoPilot Obtura expansion set consist of:1x BackFill Gun Obtura, 1x Obtura Needle Lock Nut, 4x Heat Insulator, 5x Gun-Needle Ø 25 ga, 100x Gutta Percha Bar, Accessory tools
Catalog Number
110 0133-US
Brand Name
EndoPilot Obtura set
Version/Model Number
v01
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
-
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
2717147a-6182-4bbc-995d-870c39956645
Public Version Date
October 22, 2021
Public Version Number
1
DI Record Publish Date
October 14, 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 | 11 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| U | Unclassified | 6 |