Duns Number:755003498
Device Description: Qlicksmart BladeFLASK provides a simply safer way to remove and contain used scalpel blade Qlicksmart BladeFLASK provides a simply safer way to remove and contain used scalpel blades. This world-first single-handed scalpel blade remover prevents the dangerous injuries commonly caused by removing blades with fingers, forceps or re-sheathing.
Catalog Number
-
Brand Name
BladeFLASK
Version/Model Number
QFRUSAHAV
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
K983367,K983367
Product Code
MMK
Product Code Name
Container, Sharps
Public Device Record Key
c3caeb44-5f1c-4703-a3cd-ce6591f63b48
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 24, 2016
Package DI Number
29337363001234
Quantity per Package
24
Contains DI Package
09337363001230
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 |