Duns Number:755003498
Device Description: Qlicksmart’s SnapIT ampule openers are designed to protect you from cuts when opening a gl Qlicksmart’s SnapIT ampule openers are designed to protect you from cuts when opening a glass ampule.
Catalog Number
SN-01Rb-Em Blue
Brand Name
Qlicksmart SnapIT Regular Blue
Version/Model Number
SN-01Rb
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
-
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
MDM
Product Code Name
Instrument, Manual, Surgical, General Use
Public Device Record Key
0fc94f5f-5c0e-4bd3-b3ef-7ccf98fb621f
Public Version Date
March 13, 2020
Public Version Number
1
DI Record Publish Date
March 05, 2020
Package DI Number
49337363001740
Quantity per Package
10
Contains DI Package
09337363001742
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner 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 |