Duns Number:303639066
Device Description: VACUETTE® 2 ml Virus Stabilization Tube 13x100 red cap-white ring, PREMIUM, USA
Catalog Number
456163
Brand Name
Vacuette
Version/Model Number
456163
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 27, 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
-
Product Code
JSG
Product Code Name
CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL
Public Device Record Key
a504df9b-dfdb-4bb3-bf64-50b5b9584a88
Public Version Date
May 30, 2022
Public Version Number
3
DI Record Publish Date
January 14, 2021
Package DI Number
39120049208648
Quantity per Package
24
Contains DI Package
29120049208641
Package Discontinue Date
May 27, 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 |