Duns Number:199354556
Device Description: CK-S CARR-KANTE BACK ACTION TIP (DIAMOND COATED)
Catalog Number
-
Brand Name
Ultrasonic Tips
Version/Model Number
973-1060
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
K934714
Product Code
ELC
Product Code Name
Scaler, Ultrasonic
Public Device Record Key
ad8d4628-7a5b-4210-985d-a714c29a60ef
Public Version Date
March 15, 2021
Public Version Number
1
DI Record Publish Date
March 05, 2021
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 | 98 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 595 |
| U | Unclassified | 5 |