Duns Number:324006097
Device Description: Rotary tissue punch, with centering pin 3,5 mm inner dia., red, for contra- angled han Rotary tissue punch, with centering pin 3,5 mm inner dia., red, for contra- angled handpieces
Catalog Number
7464
Brand Name
KOHDENT
Version/Model Number
7464
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
EME
Product Code Name
PUNCH, BIOPSY, SURGICAL
Public Device Record Key
f684ad7d-ca2d-44bd-9337-75e34b094b3b
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 |