Duns Number:755003498
Device Description: The BladeCASSETTE scalpel blade remover is simple to use with a quick “push, click, and pu
Catalog Number
-
Brand Name
BladeCASSETTE
Version/Model Number
QSSVCAS-BR
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"
-
For Single-Use
Yes
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
GES
Product Code Name
Blade, Scalpel
Public Device Record Key
c216b7e2-6c19-46fe-914d-21143cab47ac
Public Version Date
December 05, 2019
Public Version Number
1
DI Record Publish Date
November 27, 2019
Package DI Number
29337363000862
Quantity per Package
500
Contains DI Package
09337363000868
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 23 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |