Duns Number:303639066
Device Description: VACUETTE® TUBE 10 ml Z Urine No Additive 16x100 yellow cap-yellow ring, Round Base, non-ri VACUETTE® TUBE 10 ml Z Urine No Additive 16x100 yellow cap-yellow ring, Round Base, non-ridged
Catalog Number
455007
Brand Name
Vacuette
Version/Model Number
455007
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
-
Product Code
FMH
Product Code Name
CONTAINER, SPECIMEN, STERILE
Public Device Record Key
b357d711-fbc5-444e-ae8b-52c823bd3008
Public Version Date
July 22, 2021
Public Version Number
3
DI Record Publish Date
September 24, 2020
Package DI Number
39120017576045
Quantity per Package
24
Contains DI Package
29120017576048
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 |