Duns Number:053187985
Device Description: XDURA SCALER DE U15-109 DL-R HND
Catalog Number
-
Brand Name
NORDENT MANUFACTURING INC
Version/Model Number
TRNSU15-109
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
9aa86f25-83d6-4339-af1f-e6aca98c647b
Public Version Date
October 16, 2020
Public Version Number
1
DI Record Publish Date
October 08, 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 |