Duns Number:040729840
Device Description: CURETTE STRAIGHT CONE RING TIP #3 PHENOLIC HANDLE
Catalog Number
320-881C
Brand Name
CURETTE
Version/Model Number
320-881C
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
HTF
Product Code Name
Curette
Public Device Record Key
052d2d01-06d3-4f79-8fdb-b51dc57a9ce2
Public Version Date
June 14, 2019
Public Version Number
1
DI Record Publish Date
June 06, 2019
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 |