Duns Number:053187985
Device Description: Scaler, DE, Xdura, Anterior Offset Sickle #N67 (H6-H7), FIne Version, DuraLite ColorRing H Scaler, DE, Xdura, Anterior Offset Sickle #N67 (H6-H7), FIne Version, DuraLite ColorRing Handle
Catalog Number
-
Brand Name
NORDENT MANUFACTURING INC
Version/Model Number
CENSN67F
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ELA
Product Code Name
Instrument, Hand, Calculus Removal
Public Device Record Key
7e617486-9fff-4636-9187-30c64742d399
Public Version Date
January 05, 2021
Public Version Number
1
DI Record Publish Date
December 28, 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 | 5029 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |