Duns Number:628013963
Device Description: Floseal Matrix is indicated in surgical procedures (other than in ophthalmic) as an adjunc Floseal Matrix is indicated in surgical procedures (other than in ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
Catalog Number
ADS201883
Brand Name
FLOSEAL HEMOSTATIC MATRIX
Version/Model Number
ADS201883
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,P990009,P990009
Product Code
PMX
Product Code Name
Absorbable collagen hemostatic agent with thrombin
Public Device Record Key
50bb92ba-a4cf-4166-848d-839427ce9717
Public Version Date
October 11, 2022
Public Version Number
6
DI Record Publish Date
May 31, 2019
Package DI Number
50085412656309
Quantity per Package
6
Contains DI Package
00085412656304
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 |