Duns Number:755003498
Device Description: Qlicksmart’s SnapIT ampoule openers are designed to protect you from cuts when opening a g Qlicksmart’s SnapIT ampoule openers are designed to protect you from cuts when opening a glass ampoule.
Catalog Number
-
Brand Name
Qlicksmart SnapIT Trolley Regular
Version/Model Number
TE-01R
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"
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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
55d949e6-15eb-4d86-b628-5f26efbce0ac
Public Version Date
July 19, 2018
Public Version Number
1
DI Record Publish Date
June 18, 2018
Package DI Number
59337363001549
Quantity per Package
12
Contains DI Package
49337363001542
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 |