Duns Number:324006097
Device Description: Titanium curette LANGER 3/4 TRINOVO-P handle
Catalog Number
9551
Brand Name
KOHDENT
Version/Model Number
9551
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
EKE
Product Code Name
CURETTE, OPERATIVE
Public Device Record Key
1e4cb56c-7beb-4012-9342-1b4c19175d8e
Public Version Date
September 07, 2021
Public Version Number
1
DI Record Publish Date
August 30, 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 | 1149 |