Duns Number:530148444
Device Description: This is the Conventional Closure Configurations of IMPROVACUTER® Gel &Clot Activator Tube This is the Conventional Closure Configurations of IMPROVACUTER® Gel &Clot Activator Tube with the components of Tube, Closure, Clot Activator as well as Serum separating Gel. And the Closure is only made up of Rubber Stopper without Safety Cap. The material of Rubber Stopper is Halogenated butyl rubber.
Catalog Number
-
Brand Name
IMPROVACUTER® Gel & Clot Activator Tube
Version/Model Number
16x100mm,8.5ml
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
K093910,K093910,K093910
Product Code
JKA
Product Code Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Public Device Record Key
9c02f6fd-82db-4b05-bb1b-b7569c19bcd6
Public Version Date
November 10, 2021
Public Version Number
2
DI Record Publish Date
April 26, 2019
Package DI Number
46933395621869
Quantity per Package
20
Contains DI Package
16933395621868
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 32 |