Duns Number:040729840
Device Description: WHITESIDE SCALER #2 SINGLE ENDED TAPERED BLADE SMALL SIZE SHORT REACH STRAIGHT SHANK LIGHT WHITESIDE SCALER #2 SINGLE ENDED TAPERED BLADE SMALL SIZE SHORT REACH STRAIGHT SHANK LIGHT HANDLE
Catalog Number
1102-RESCW2
Brand Name
WHITESIDE SCALER
Version/Model Number
1102-RESCW2
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"
Yes
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
EMN
Product Code Name
Scaler, Periodontic
Public Device Record Key
1114956b-50db-4b27-bf82-2c226ad116eb
Public Version Date
September 17, 2019
Public Version Number
3
DI Record Publish Date
August 21, 2019
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 | 10108 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3414 |