Duns Number:628013963
Device Description: FLOSEAL Hemostatic Matrix, 10mL
Catalog Number
ADS201845
Brand Name
FLOSEAL HEMOSTATIC MATRIX
Version/Model Number
ADS201845
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
101b306f-5a7b-4f0a-9c8e-b15fd5c15d02
Public Version Date
October 11, 2022
Public Version Number
4
DI Record Publish Date
July 30, 2019
Package DI Number
50085412639609
Quantity per Package
6
Contains DI Package
00085412639604
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 |