Duns Number:755003498
Device Description: The Qlicksmart BladeFlask EVO provides a simply safer way to remove used scalpel blades an The Qlicksmart BladeFlask EVO provides a simply safer way to remove used scalpel blades and can accommodate different types of scalpel handles and blades including large autopsy scalpels, thick and round handles, even hexagonal shaped versions - giving you greater freedom in using any scalpel you want. It is so simple to use with just one hand. Embrace safety with the new standard in scalpel blade removals and prevent the dangerous injuries commonly caused by removing blades with fingers, forceps or re-sheathing.
Catalog Number
-
Brand Name
BladeFlask EVO Blade Remover
Version/Model Number
QBVRGEN
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
3da95e07-2572-444e-a6a2-b4f5f26b9db7
Public Version Date
February 04, 2021
Public Version Number
1
DI Record Publish Date
January 27, 2021
Package DI Number
29337363001760
Quantity per Package
24
Contains DI Package
09337363001766
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| 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 |