Duns Number:040729840
Device Description: ANTERIOR SCALETTE #N137ML MODERATE SIZE MEDIUM REACH TAPERED TO POINT/ SHARP EDGES ROUND T ANTERIOR SCALETTE #N137ML MODERATE SIZE MEDIUM REACH TAPERED TO POINT/ SHARP EDGES ROUND TOE LONG REACH LIGHT HANDLE
Catalog Number
1102-RESCN137ML
Brand Name
ANTERIOR SCALETTE
Version/Model Number
1102-RESCN137ML
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
8e30b289-9b2c-4838-a191-12e9686437d9
Public Version Date
September 09, 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 |