Duns Number:040729840
Device Description: SICKLE SCALER #IVORY Cl1/WHITESIDE #2 DOUBLE ENDED MODERATE SIZE SHORT REACH/SMALL SIZE SH SICKLE SCALER #IVORY Cl1/WHITESIDE #2 DOUBLE ENDED MODERATE SIZE SHORT REACH/SMALL SIZE SHORT REACH STRAIGHT SHANK
Catalog Number
1102-SCCI1-W2
Brand Name
SICKLE SCALER
Version/Model Number
1102-SCCI1-W2
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
EMN
Product Code Name
SCALER, PERIODONTIC
Public Device Record Key
245f03e1-0e24-4fef-a719-63f4471df208
Public Version Date
September 10, 2019
Public Version Number
4
DI Record Publish Date
September 17, 2018
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 |