Duns Number:040729840
Device Description: Lingual Curette #45-46 Double End Opposing 10 Degree Angle 2.5 Millimeter Blades Straight Lingual Curette #45-46 Double End Opposing 10 Degree Angle 2.5 Millimeter Blades Straight Shank
Catalog Number
-
Brand Name
Lingual Curette
Version/Model Number
1102-SC45-46
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
EMK
Product Code Name
CURETTE, SURGICAL, DENTAL
Public Device Record Key
0c359866-b671-4f74-aa26-4abac0b8bd7d
Public Version Date
February 18, 2021
Public Version Number
1
DI Record Publish Date
February 10, 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 | 10108 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3414 |