Duns Number:755003498
Device Description: BladeCARTRIDGE is available as an add-on to the Qlicksmart BladeNeedleSYSTEM if you need m BladeCARTRIDGE is available as an add-on to the Qlicksmart BladeNeedleSYSTEM if you need more scalpel blade removers in this needle holder.
Catalog Number
-
Brand Name
BladeCARTRIDGE-1
Version/Model Number
QSSVCAT-1
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
56244c1d-fce2-4955-a9d1-389dda6d79e6
Public Version Date
October 15, 2018
Public Version Number
1
DI Record Publish Date
September 12, 2018
Package DI Number
29337363001623
Quantity per Package
4
Contains DI Package
19337363001626
Package Discontinue Date
-
Package Status
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 |