Duns Number:040729840
Device Description: Sickle Offset Scaler #N67 Light Handle Double End 0.9 Millimeters Taper Blades 10 Degree R Sickle Offset Scaler #N67 Light Handle Double End 0.9 Millimeters Taper Blades 10 Degree Reach
Catalog Number
-
Brand Name
Sickle Offset Scaler
Version/Model Number
1102-RESCN67
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
6ef6a2c9-c1cf-419f-9c23-e6080d8f8ae2
Public Version Date
January 08, 2021
Public Version Number
1
DI Record Publish Date
December 31, 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 | 10108 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3414 |