Duns Number:388240673
Device Description: Determination of prothrombin time (PT) and of the activity of coagulation factors II, V, V Determination of prothrombin time (PT) and of the activity of coagulation factors II, V, VII and X
Catalog Number
OUHP31
Brand Name
Thromborel® S
Version/Model Number
10873564
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 22, 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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K003870,K003870
Product Code
GJS
Product Code Name
TEST, TIME, PROTHROMBIN
Public Device Record Key
50060083-e3c1-4cdc-a15b-69a0568a6cfa
Public Version Date
August 23, 2022
Public Version Number
6
DI Record Publish Date
February 15, 2017
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 | 25 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 101 |