Duns Number:687789453
Device Description: PEESO REAMERS is used for preparation of coronal third and picking up the fillings inside PEESO REAMERS is used for preparation of coronal third and picking up the fillings inside the root canal
Catalog Number
541-206
Brand Name
PEESO REAMERS
Version/Model Number
32m/m 6
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
DZA
Product Code Name
Drill, Dental, Intraoral
Public Device Record Key
b9364633-8c78-4c4f-8cba-a57228989058
Public Version Date
June 23, 2020
Public Version Number
1
DI Record Publish Date
June 15, 2020
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 | 4806 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 158 |