Duns Number:276075371
Device Description: Endodontic instrument for professionnal dental use only
Catalog Number
20118008
Brand Name
SHAPER
Version/Model Number
n25 L25
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
EKW
Product Code Name
Broach, Endodontic
Public Device Record Key
52278b5c-bef0-438b-817e-709cdc047664
Public Version Date
September 18, 2020
Public Version Number
1
DI Record Publish Date
September 10, 2020
Package DI Number
J015201180089
Quantity per Package
10
Contains DI Package
J015201180081
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
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 |