Duns Number:554555378
Catalog Number
-
Brand Name
IMPROVACUTER® Gel & Clot Activator Tube
Version/Model Number
13×75mm,3ml
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
f00f5414-06d5-4c45-b7ec-f6e973251b6d
Public Version Date
July 04, 2022
Public Version Number
1
DI Record Publish Date
June 24, 2022
Package DI Number
46974481831380
Quantity per Package
10
Contains DI Package
16974481831389
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 |