Duns Number:755003498
Device Description: The BladeCASSETTE scalpel blade remover is simple to use with a quick “push, click, and pu The BladeCASSETTE scalpel blade remover is simple to use with a quick “push, click, and pull” action to remove and contain used scalpel blades.Used together with a hands-free passing technique, the Qlicksmart BladeCASSETTE scalpel blade remover can prevent up to 5 times more injuries than a safety scalpel. This easy-to-use solution provides a low cost alternative to safety scalpels, allowing surgeons to maintain their preferences for the standard metal handle. Qlicksmart BladeCASSETTE scalpel blade remover is award-winning, which demonstrate its practicality and effectiveness in reducing scalpel injuries.
Catalog Number
-
Brand Name
BladeCASSETTE
Version/Model Number
QSSVCAS-3Y
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 06, 2019
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
f7030a7e-10ca-4d4d-b098-45be86b28d1f
Public Version Date
December 09, 2019
Public Version Number
2
DI Record Publish Date
November 27, 2019
Package DI Number
29337363001654
Quantity per Package
4
Contains DI Package
19337363001657
Package Discontinue Date
December 06, 2019
Package Status
Not in Commercial Distribution
Package Type
Outer 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 |