Duns Number:303639066
Device Description: Urine Beaker with Safety Stopper 100 ml, white lid single-packed, sterile
Catalog Number
724300
Brand Name
Vacuette
Version/Model Number
724300
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 03, 2021
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
a8b5e9ae-9935-40c1-b873-2e0961a6c996
Public Version Date
December 06, 2021
Public Version Number
3
DI Record Publish Date
October 05, 2020
Package DI Number
39120017578056
Quantity per Package
100
Contains DI Package
29120017578059
Package Discontinue Date
December 02, 2021
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 |