Duns Number:303639066
Device Description: VACUETTE® QUICKSHIELD Complete PLUS 21G x 1 1/2" single-packed, sterile 0.80 x 38 mm
Catalog Number
450239V1
Brand Name
Vacuette
Version/Model Number
450239V1
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)
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
0a69f572-8d98-4f06-94ba-4f1391fc8849
Public Version Date
August 14, 2019
Public Version Number
1
DI Record Publish Date
August 06, 2019
Package DI Number
39120049209034
Quantity per Package
12
Contains DI Package
29120049209037
Package Discontinue Date
-
Package Status
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 |