Duns Number:755003498
Device Description: The Qlicksmart BladeNeedleSYSTEM is two safety devices in one – the world’s only single-ha The Qlicksmart BladeNeedleSYSTEM is two safety devices in one – the world’s only single-handed scalpel blade remover is combined with the standard needle counter to allow an accurate count and efficient disposal of both scalpel blades and suture needles.
Catalog Number
-
Brand Name
BladeNeedleSYSTEM
Version/Model Number
QBNS202B-R
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
GAB
Product Code Name
Needle, Suturing, Disposable
Public Device Record Key
06af20c7-580c-441d-a194-9c5b849b73bf
Public Version Date
December 05, 2019
Public Version Number
1
DI Record Publish Date
November 27, 2019
Package DI Number
29337363001739
Quantity per Package
144
Contains DI Package
09337363001735
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 |