Duns Number:324006097
Device Description: Mixing spatula ( hollow ) / condenser 3 mm with stop - 17,5 cm -
Catalog Number
7290
Brand Name
KOHDENT
Version/Model Number
7290
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
GAF
Product Code Name
SPATULA, SURGICAL, GENERAL & PLASTIC SURGERY
Public Device Record Key
d73a7a77-9787-4a8c-821a-81ca54f4a362
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 |