Duns Number:276075371
Device Description: Endodontic instrument for professionnal dental use only
Catalog Number
20948201
Brand Name
One G
Version/Model Number
n014 3% L21 Classics Sterile
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
EKS
Product Code Name
File, Pulp Canal, Endodontic
Public Device Record Key
d2fa46a2-d019-4d50-bc51-dbf55990cce0
Public Version Date
September 29, 2022
Public Version Number
1
DI Record Publish Date
September 21, 2022
Package DI Number
J015209482019
Quantity per Package
10
Contains DI Package
J015209482011
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 | 64 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |