Duns Number:013799942
Device Description: VACUETTE 3ml Virus Stabilization Tube 1200 pcs
Catalog Number
-
Brand Name
Keystone VACUETTE 3ml Virus Stabilization Tube 1200 pcs
Version/Model Number
KMVIAL-VAC3ML-1200
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KDT
Product Code Name
Container, Specimen Mailer And Storage, Sterile
Public Device Record Key
7aa5fcff-ad8b-4f4b-8cff-2a3e2d92b6c4
Public Version Date
August 25, 2021
Public Version Number
1
DI Record Publish Date
August 17, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 16 |
2 | A medical device with a moderate to high risk that requires special controls. | 4 |