Duns Number:080478537
Device Description: SUPERCUT KERRISON RONGEUR 7" 3MM BITE 40 DEGREE
Catalog Number
-
Brand Name
CLEAR FLUSH
Version/Model Number
SC7-3MM40
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 20, 2018
Issuing Agency
In HIBCC
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"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HAE
Product Code Name
Rongeur, Manual
Public Device Record Key
18c504ab-9170-414d-aa24-8fc96c43ade2
Public Version Date
July 12, 2019
Public Version Number
4
DI Record Publish Date
February 21, 2017
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 | 7 |
2 | A medical device with a moderate to high risk that requires special controls. | 181 |