Duns Number:628013963
Device Description: FLOSEAL Hemostatic Matrix, 10 mL
Catalog Number
1505291
Brand Name
Floseal
Version/Model Number
1505291
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
P990009,P990009
Product Code
PMX
Product Code Name
Absorbable collagen hemostatic agent with thrombin
Public Device Record Key
6547cd71-1fd2-49a3-a275-cc0451fe8ff0
Public Version Date
October 11, 2022
Public Version Number
5
DI Record Publish Date
April 12, 2017
Package DI Number
50085412532863
Quantity per Package
6
Contains DI Package
00085412532868
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| 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. | 101 |
| 3 | A medical device with high risk that requires premarket approval | 19 |