Duns Number:008999906
Catalog Number
-
Brand Name
Thrombi-Gel® thrombin/gelatin foam hemostat
Version/Model Number
0907
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 18, 2022
Issuing Agency
In HIBCC
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
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
143b3750-437e-4441-954f-b211247c6288
Public Version Date
February 18, 2022
Public Version Number
6
DI Record Publish Date
September 15, 2016
Package DI Number
M20609071
Quantity per Package
10
Contains DI Package
M20609070
Package Discontinue Date
February 18, 2022
Package Status
Not in Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 238 |
| U | Unclassified | 12 |