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 conventionalprocedures is ineffective or impractical.
Catalog Number
1503352
Brand Name
Floseal Hemostatic Matrix
Version/Model Number
1503352
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LMF
Product Code Name
Agent, Absorbable Hemostatic, Collagen Based
Public Device Record Key
186daf30-43ae-4108-95b7-78c2122ef99c
Public Version Date
October 11, 2022
Public Version Number
4
DI Record Publish Date
October 09, 2017
Package DI Number
50085412096129
Quantity per Package
6
Contains DI Package
00085412096124
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 |