Duns Number:303639066
Device Description: VACUETTE® QUICKSHIELD Complete PLUS 22G x 1" single-packed, sterile 0.7 x 25 mm
Catalog Number
450226
Brand Name
Vacuette
Version/Model Number
450226
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 08, 2022
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K072320,K072320,K072320
Product Code
FMI
Product Code Name
Needle, hypodermic, single lumen
Public Device Record Key
022888f1-5c80-4454-8c00-63db4b2ff100
Public Version Date
September 09, 2022
Public Version Number
5
DI Record Publish Date
September 23, 2016
Package DI Number
39120017577745
Quantity per Package
10
Contains DI Package
29120017577748
Package Discontinue Date
September 01, 2022
Package Status
Not 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 | 18 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 21 |